Janhavi Rao - Academia.edu (original) (raw)

Papers by Janhavi Rao

International Journal of Pharmacy and Pharmaceutical Sciences, Sep 1, 2014

Objective: The present study was designed with an objective of a simple, fast, precise, selective... more Objective: The present study was designed with an objective of a simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Aspirin, Ramipril, Hydrochlorothiazide, Simvastatin and Atenolol from bulk drug and formulation. Methods: The separation was achieved on a Hypersil Gold column (250 mm X 4.6 mm, 5 µ) as stationary phase with a mobile phase consisting of methanol: water in the ratio of 95:5% v/v at a flow rate of 1 mL/min and UV detection at 230 nm. Results: The retention times were observed to be 1.983, 2.525, 3.108, 3.867 and 7.833 minutes for Aspirin, Ramipril, Hydrochlorothiazide, Simvastatin and Atenolol, respectively. The method was statistically validated for linearity, recovery, the limit of detection, limit of quantification, accuracy and precision. Conclusion: Thus, proposed method was found sensitive, precise, accurate and specific and be used for quantitative estimation of Aspirin, Ramipril, hydrochlorothiazide, Simvastatin and Atenolol in commercial pharmaceutical dosage form.

Research Journal of Pharmacy and Technology, Mar 28, 2010

Asian Journal of Pharmaceutical and Clinical Research, Mar 1, 2017

Objective: The objective of this study was to develop and validate a simple, precise and accurate... more Objective: The objective of this study was to develop and validate a simple, precise and accurate reverse phase high performance liquid chromatographic method for simultaneous estimation of dicyclomine hydrochloride, paracetamol, and mefenamic acid from multicomponent tablet dosage form. Methods: The optimized chromatographic separation was achieved using a stationary phase of hypersil gold ODS-C18 (250 × 4.6 mm i.d, 5 μm particle size) column and mobile phase of acetonitrile: Methanol: Potassium dihydrogen phosphate buffer, pH adjusted to 4.5 with orthophosphoric acid (OPA) in the ratio of 50: 30: 20 (v/v/v) with a flow rate of 1 mL/minute. The ultraviolet detection was carried out at 260 nm. Results: The retention times of paracetamol, dicyclomine hydrochloride and MEF were found to be 4.2, 6.1 and 3.4 minutes, respectively. The method was validated for linearity, precision, accuracy, and robustness. The developed method provided linear responses within the concentration ranges 2-12 µg/mL for dicyclomine hydrochloride, 50-300 µg/mL for paracetamol, and 25-150 µg/mL for MEF. The % recovery obtained were found to be 99.09-99.44% for dicyclomine hydrochloride, 99.22-99.51% for paracetamol, and 99.49-99.60 for MEF. Conclusion: The proposed method enables rapid quantification and simultaneous analysis of all the drugs from commercial formulations without any interference of excipients. Hence, the developed method can be successfully applied for routine analysis of dicyclomine hydrochloride, paracetamol, and MEF in their combined tablet formulation.

Pharmaceutical Drug Regulatory Affairs Journal

The medical device market in India is a sunrise sector in the pharmaceutical industry and has ach... more The medical device market in India is a sunrise sector in the pharmaceutical industry and has achieved a milestone in the last few years securing 4th position in the medical device market in Asia with increasing foreign direct investments through governments Make in India Campaign 2017, and PLI (Product linked incentive) schemes. To enter the medical device market in any country, one has to go through different procedures and regulatory requirements of that country. Medical devices are regulated in India by the DCGI (Drug Controller General of India) under the CDSCO (Central Drug Standard Control Organization). In China, the registration approval process is under NMPA (National Medical Product Administration) and requires complying with Chinese regulatory standard notice No. 218. Europe and Australian regulations are bit same and require a CE (Conformité Européenne) mark for manufacturing and marketing. U.S. regulations for approving medical devices are stringent and 510 (k) and PMA...

Objective: The present study was designed with an objective of a simple, fast, precise, selective... more Objective: The present study was designed with an objective of a simple, fast, precise, selective and accurate HPTLC method was developed and validated for the simultaneous determination of bisoprolol fumarate and hydrochlorothiazide from bulk and formulations. Methods: High performance thin layer chromatography (HPTLC) method was developed and validated for rapid analysis of simultaneous determination of bisoprolol fumarate and hydrochlorothiazide. Chromatographic separation was achieved on precoated silica gel HPTLC aluminum plate 60 F254 using ethyl acetate: methanol: ammonia 10:0.5:0.5 (v/v) as mobile phase. Detection was performed at 225 nm wavelength densitometrically. Results: The RF of bisoprolol fumarate and hydrochlorothiazide were 0.60 and 0.38, respectively. Linearity was observed in the concentration range of 150-900 ng/spot for bisoprolol fumarate and 100-600 ng/spot for hydrochlorothiazide. Percent recoveries obtained for both the drugs were 99.45 ± 0.06% for bisoprol...

Objective: To develop and subsequently validate a new simple and sensitive high performance thin ... more Objective: To develop and subsequently validate a new simple and sensitive high performance thin layer chromatographic (HPTLC) method for estimation of Levocetirizine, Pseudoephedrine and Ambroxol simultaneously, from a bulk drug and combined dosage form. Method: The separation of drugs was carried out on Merck HPTLC aluminium sheets of silica gel 60 F254 as stationary phase and the chromatogram was developed using Ethyl-acetate: methanol: ammonia (8: 1: 0.5 v/v/v) as the mobile phase. Result: Levocetirizine, Pseudoephedrine and Ambroxol showed Rf values 0.1 ± 0.02, 0.39 ± 0.05, and 0.73 ± 0.05 respectively, when scanned densitometrically at 212 nm using Camag TLC Scanner. The described method was linear over a concentration range of 100 ng spot-1 to 700 ng spot-1, 600 ng spot-1 to 4200 ng spot-1 and 1200 ng spot-1 to 8400 ng spot-1 for the Levocetirizine, Pseudoephedrine and Ambroxol respectively. Results of analysis were validated according to International Conference on Harmoniza...

Research Journal of Pharmacy and Technology, 2020

Indian Journal of Experimental Biology (IJEB), Sep 30, 2020

Loss of erythrocyte membrane deformability is one of the most crucial factors in developing compl... more Loss of erythrocyte membrane deformability is one of the most crucial factors in developing complications associated with Type II diabetes. The observed loss of erythrocyte membrane deformability could be related to structural changes in the membrane. In this context, here, we have made an attempt at gaining a better insight (quantitative as well as qualitative) into the protein and lipid contents in erythrocyte membranes and their interrelationships in Type II diabetes. Age matched control (n=12) and Type II diabetic subjects (n=22) were selected for this study. Morphological characteristics were studied by atomic force microscopy (AFM). AFM study confirmed remarkable alterations in morphology of the diabetic erythrocytes. In diabetic erythrocytes following changes were noted: (i) Significant increase in membrane as well as cytosolic proteins with a marginal increase in phospholipids content; (ii) The membrane total lipids:protein, phospholipids:protein, cholesterol:protein and phospholipids:cholesterol (mole:mole) ratios decreased significantly; (iii). A reproducible decrease in docosahexaenoic acid (DHA) and Omega-3 index with increase in Omega-6:Omega-3 ratio in membrane fatty acids; and (iv) The SDS-PAGE analysis indicated that all membrane proteins increased in almost equal proportion leading to increased membrane protein content. The observed compositional and stochiometric changes in lipids, proteins and their ratios may underlie morphological alterations and loss of deformability.

international journal of chemical sciences, 2008

A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic... more A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of racecadotril in bulk drug and its dosage form was developed and validated. The method employed Merck HPTLC aluminum sheets of silica gel 60F 254 as the stationary phase. The solvent system consisted of chloroform : methanol (9.8 : 0.2 v/v). This system was found to give compact spots for racecadotril (R f 0.61 ± 0.02). Racecadotril was subjected to acid and alkali hydrolysis, oxidation and photodegradation, and the degraded products were well separated from pure drug. Densitometric analysis of racecadotril was carried out in the remission-absorbance mode at 232 nm. The linear regression analysis data for the calibration plots showed good linear relationship with coefficient of regression value, r 2 = 0.9994 in the concentration range of 100-1000 ng per spot. The mean value of correlation coefficient, slope and intercept were 0.9995 ± 1.88, 0.352 ± 0.02 and 5.205 ± 0.05, respectively. The limits of detection and quantitation were 200 and 600 ng per spot, respectively. The method was validated as per ICH guidelines for precision, recovery and robustness. Racecadotril samples on being degraded with hydrogen peroxide showed additional peaks at R f 0.006 and 0.64 while the drug on being subjected to acidic and basic hydrolysis showed additional peaks at R f 0.50 and 0.18, respectively. This indicates that the drug is susceptible to acid-base hydrolysis degradation, oxidation and photochemical degradation. Statistical analysis proves that the method is reproducible and selective for the estimation of the said drug. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.

Journal of analytical and bioanalytical techniques, Oct 10, 2019

Asian Journal of Research in Chemistry, 2012

A rapid assay procedure have been developed for the determination of Nebivolol hydrochloride base... more A rapid assay procedure have been developed for the determination of Nebivolol hydrochloride based on application of oxidant to the spectrophotometry and high performance thin layer chromatography (HPTLC) have been developed for simultaneous determination of Nebivolol hydrochloride and Hydrochlorothiazide in a bulk drug and pharmaceutical formulation. In spectrophotometric method, Nebivolol Hydrochloride is treated with a known excess of cerium (IV) sulphate and the residual oxidant is determined by treating with a fixed amount of indigo carmine, and measuring the absorbance at 610 nm and Chromatographic separation was achieved on aluminum foil plates precoated with silica gel 60GF-254, with chloroform: toluene: methanol: ammonia (5:3:2:0.1, v/v/v/v) as mobile phase. Detection was performed densitometrically at 278 nm. The RF of Nebivolol and Hydrochlorothiazide were 0.30 and 0.42, respectively. In spectrophotometry, Beer's law is obeyed over concentration range of 2–10 μg/mL. T...

Herbal cosmetics also known as "natural cosmetics". with the beginning of the civilization, manki... more Herbal cosmetics also known as "natural cosmetics". with the beginning of the civilization, mankind had the magnetic dip towards impressing others with their looks. At the time, there were no fancy fairness creams or any cosmetic surgeries. The only thing they had was the knowledge of nature, compiled in the ayurveda. With the science of Ayurveda, several herbs and floras were used to make Ayurvedic cosmetics that really worked. Ayurvedic cosmetics not only beautified the skin but acted as the shield against any kind of external affects for the body. The aim of the present study is focused to formulate a stable cream containing different herbs. Herbal cosmetics are the preparations used to enhance the human appearance. Aegle Marmelos (bael fruit), Aloe barbadensis (Aloe vera leaves), Curcuma longa (Turmericrhizomes), Prunus dulcis (Almond oil), Cucumis Sativus (cucumber) were selected. This study was carried out to formulate a cream for the purpose of nourishing, lightening, antiwrinkle, moisturizer, wound healer and antimicrobial activity. This herbal formulation was characterised for its spreadibility, good consistency, pH, non greasy and for no evidence of creaming. The cream was in the form of O/W emulsion and there was no phase separation. Various evaluation studies were performed including stability test, patch test, microbial test, pH, irritation test, etc; which proved that the prepared herbal cream is safe and effective to use.

Letters in Drug Design & Discovery, Feb 1, 2022

Background: Thymidine Phosphorylase (TP) is an imperative target for cancer researchers. In the c... more Background: Thymidine Phosphorylase (TP) is an imperative target for cancer researchers. In the current research, quantitative structure-activity relationship (QSAR) models were demonstrated to identify new TP inhibitors. Objective: The main objective is to perform a QSAR study on a series of 19 derivatives of thiobarbituric acid and new molecules designed and dock to check potency and efficacy for anticancer activity. Methods: Multiple linear regression analysis (MLR) was used to establish a two-dimensional quantitative structure-activity relationship (2D-QSAR) with regression coefficient values of 0.9781, 0.9513, and 0.9819 for the training set (r2), leave-one-out (LOO) dependent internal regression (q2), and external test set regression (r2 _pred), respectively. Three-dimensional quantitative structure-activity relationship (3DQSAR) model, obtained by using the simulated annealing k nearest neighbour (SA-KNN) method (q2 = 0.7880). Newly designed molecules were subjected to docking studies with 7-deazaxanthine taken as standard. Results: Molecular modelling, structure-based drug design and docking study analysis were performed. The new chemical entities (NCE’s) designed, docked towards targeted receptor and show good results as compared to the standard 7-deazaxanthine. It was found that these molecules bind similar amino acid pocket regions as that of standard. Molecules bind at the active site of TP enzyme involving H bond interactions with shorter distances showed greater affinity. At last, the oral bioavailability and toxic effect were evaluated as absorption, distribution, metabolism, and elimination (ADME) studies by computational means of the Qikprop tool of Schrodinger. Conclusion: One of the most successful and fast-increasing methodologies is molecular modelling. It not only aids in the prediction of specific target compounds but also aids in the cost reduction of valuable substances. QSAR and docking study was performed, and most of the molecules have shown good dock scores. Based on these results, NCE’s for anticancer activity were successfully designed and analysed in this research work which will be helpful for effective drug synthesis with less toxicity in the future. Others: 2D QSAR model was generated by three methods, and the best one was selected for further study. NCEs were planned based on descriptors such as topological, electrostatic, steric, and hydrophobic substitutions around the core.

Letters in Drug Design & Discovery

Background: Thymidine Phosphorylase (TP) is an imperative target for cancer researchers. In the c... more Background: Thymidine Phosphorylase (TP) is an imperative target for cancer researchers. In the current research, quantitative structure-activity relationship (QSAR) models were demonstrated to identify new TP inhibitors. Objective: The main objective is to perform a QSAR study on a series of 19 derivatives of thiobarbituric acid and new molecules designed and dock to check potency and efficacy for anticancer activity. Methods: Multiple linear regression analysis (MLR) was used to establish a two-dimensional quantitative structure-activity relationship (2D-QSAR) with regression coefficient values of 0.9781, 0.9513, and 0.9819 for the training set (r2), leave-one-out (LOO) dependent internal regression (q2), and external test set regression (r2 _pred), respectively. Three-dimensional quantitative structure-activity relationship (3DQSAR) model, obtained by using the simulated annealing k nearest neighbour (SA-KNN) method (q2 = 0.7880). Newly designed molecules were subjected to dockin...

A simple, specific, accurate and precise HPTLC method for simultaneous estimation of paracetamol,... more A simple, specific, accurate and precise HPTLC method for simultaneous estimation of paracetamol, lornoxicam and chlorzoxazone as the bulk drug and in tablet dosage form. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of chloroform: toluene: methanol: glacial acetic acid 6: 3: 1: 0.04 (v/v/v/v). Densitometric evaluation of the separated zones was performed at 275 nm. The three drugs were satisfactorily resolved with RF values 0.26 ± 0.02, 0.45 ± 0.03 and 0.53 ± 0.01 for paracetamol, lornoxicam and chlorzoxazone respectively. The method can be used for estimation of combination of these drugs in tablets. The method was validated as per ICH guidelines. The linearity of developed method was achieved in the range of 10 – 50 ng/spot for each of paracetamol, lornoxicam and chlorzoxazone and recoveries from tablets were between 99.27 ± 0.70, 99.37 ± 0.06 and 99.10 ± 0.30 %. ...

Research presents simple, rapid and economical method for the simultaneous analysis estimation of... more Research presents simple, rapid and economical method for the simultaneous analysis estimation of both the drugs from pharmaceutical dosage form. MATERIALS AND METHODS Materials Paracetamol and Lornoxicam were obtained as a gift sample by Itros Pharmaceutical Ltd. Pune. Methanol (HPLC grade) was purchased from Merck Chemicals Limited, Mumbai. In-house double distilled water was used throughout the study. Fixed dose combination tablet (Lornsafe-plus) containing 500mg paracetamol and 8mg lornoxicam were procured from local market. Instrumentation The HPLC system consisted of Intelligent HPLC pump model (Jasco PU 2080 Plus) with sampler programmed at 20 μL capacity per injection was used. The detector consisted of a UV/ VIS (Jasco UV 2075 Plus). Data was integrated using Jasco Borwin version 1.5, LC-Net II/ADC system. ODS HyperSil C18 (250 mm, 4.6 mm, 5 μm) column was used, Japan. Preparation of standard and sample solutions The standard stock solution was prepared by transferring 10 mg of paracetamol and 10mg lornoxicam in a 10 mL volumetric flask. Add about 10 mL of mobile phase and sonicate to dissolve. Dilute 0.1mL of this solution to 10mL with Mobile phase and mix. Final standard concentration of paracetamol and lornoxicam is 10 μg/mL. Lornsafe-plus 20 intact tablets were accurately weighed to determine average weight of tablets. Then tablets were finely crushed and tablet powder equivalent to about 500mg of paracetamol and 8mg of lornoxicam was transferred into 100 mL volumetric flask. Then 60 mL methanol was added to flask and sonicated for 30 minutes with intermittent shaking. Make the volume up to mark with mobile phase ABSTRACT A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of paracetamol and lornoxicam from tablets by reverse phase C18 column ODS HyperSil (250 mm, 4.6 mm, 5 μm). The sample was analyzed using methanol: water (85:15, v/v), as a mobile phase at a flow rate of 1 mL/min. and detection at 259 nm. The retention time for paracetamol and lornoxicam was found to be 3.30 min and 2.14 min, respectively. The method can be used for estimation of combination of these drugs in tablets. The method was validated as per ICH guidelines. The linearity of developed method was achieved in the range of 0.4-1.4 μg/mL for paracetamol and 0.6-1.6 μg/ mL for lornoxicam and recoveries from tablets were between 100.36% and 100.17%. Due to these attributes, the proposed method could be used for routine quality control analysis of these drugs in combined dosage forms.

Indian drugs, 2003

A simple, specific and precise high performance thin layer chromatographic method has been develo... more A simple, specific and precise high performance thin layer chromatographic method has been developed for mosapride citrate in its tablet dosage form. In this method, standard solutions and sample solutions of Mosapride citrate were applied on precoated Silica gel G60 F 2 5 0 TLC plate and developed using a mixture of toluene: Methanol (80.20 V/V) as mobile phase. Quantification was carried out by the use of densitometer absorbance mode at 306 nm. This HPTLC system was quantitatively evaluated in terms of stability, precision, repeatability, specificity, accuracy and calibration proving the utility in the analysis of its tablet dosage forms.

A simple, selective, precise and stability-indicating high-performance thin layer chromatographic... more A simple, selective, precise and stability-indicating high-performance thin layer chromatographic method for analysis of bumetanide (BUM), both as the bulk drug and in a tablet formulation, has been developed and validated. Aluminium foil TLC plates precoated with silica gel 60F254 were used as stationary phase and toluene: ethyl acetate: formic acid (7: 3.5: 0.5, v/v/v) as mobile phase. A compact band (RF 0.45 ± 0.02) was obtained for BUM. Densitometric analysis was performed in absorbance mode at 335 nm. Linear regression analysis revealed a good linear relationship (r2 = 0.9996) between peak area and concentration in the range 100–800 ng/spot. The mean values ± RSD of the slope and intercept were 0.9987 ± 0.965 and 23.471 ± 1.24, respectively. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 30 and 80 ng/spot, respectively. BUM was subjected to acid and alkaline hydrolysis, oxidation, and photochemical and thermal deg...

High performance thin layer chromatographic method has been developed for the simultaneous determ... more High performance thin layer chromatographic method has been developed for the simultaneous determination of Propranolol hydrochloride and Hydrochlorothiazide from bulk and formulations. Chromatographic separation was achieved on aluminum foil plates precoated with silica gel 60F254, with chloroform: ethyl acetate: methanol 4: 4: 2 (v/v/v) as mobile phase. Detection was performed densitometrically at 274 nm. The Rf of Propranolol hydrochloride and Hydrochlorothiazide were 0.27± 0.02 and 0.56 ± 0.02, respectively. Parameters such as linearity, precision, accuracy, specificity and robustness are studied as reported in the ICH guidelines. Linearity was observed in the concentration range of 160-960 ng/band for Propranolol hydrochloride and 100-600 ng/band for Hydrochlorothiazide. The mean recoveries obtained for Propranolol hydrochloride and Hydrochlorothiazide were 99.63 % and 99.15 % respectively. Developed method was found to be accurate, precise, selective and rapid for simultaneous...

Micellar liquid chromatographic method has been developed for the simultaneous determination of P... more Micellar liquid chromatographic method has been developed for the simultaneous determination of Propranolol hydrochloride and Hydrochlorothiazide from bulk and formulations. Chromatographic separation achieved isocratically on ODS hypersil C18 column (5 μm, 250 mm × 4.6 mm) and micellar mobile phase of 0.07M sodium dodecyl sulfate (SDS) pH 3 adjusted with phosphate buffer and 15 % (v/v) 1- propanol as organic modifier in the ratio 70: 30 v/v and ultraviolet detection at 274 nm are used for the determination. In the developed method Propranolol hydrochloride and Hydrochlorothiazide elute at typical retention times of 6.767 min and 2.633 min, respectively at a 1 mL/min flow rate. Parameters such as linearity, precision, accuracy, specificity and robustness are studied as reported in the ICH guidelines. Linearity was observed in the concentration range of 4-24 μg/mL for Propranolol hydrochloride and and 2.5-15 μg/mL for Hydrochlorothiazide. The mean recoveries obtained for Propranolol ...

International Journal of Pharmacy and Pharmaceutical Sciences, Sep 1, 2014

Objective: The present study was designed with an objective of a simple, fast, precise, selective... more Objective: The present study was designed with an objective of a simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Aspirin, Ramipril, Hydrochlorothiazide, Simvastatin and Atenolol from bulk drug and formulation. Methods: The separation was achieved on a Hypersil Gold column (250 mm X 4.6 mm, 5 µ) as stationary phase with a mobile phase consisting of methanol: water in the ratio of 95:5% v/v at a flow rate of 1 mL/min and UV detection at 230 nm. Results: The retention times were observed to be 1.983, 2.525, 3.108, 3.867 and 7.833 minutes for Aspirin, Ramipril, Hydrochlorothiazide, Simvastatin and Atenolol, respectively. The method was statistically validated for linearity, recovery, the limit of detection, limit of quantification, accuracy and precision. Conclusion: Thus, proposed method was found sensitive, precise, accurate and specific and be used for quantitative estimation of Aspirin, Ramipril, hydrochlorothiazide, Simvastatin and Atenolol in commercial pharmaceutical dosage form.

Research Journal of Pharmacy and Technology, Mar 28, 2010

Asian Journal of Pharmaceutical and Clinical Research, Mar 1, 2017

Objective: The objective of this study was to develop and validate a simple, precise and accurate... more Objective: The objective of this study was to develop and validate a simple, precise and accurate reverse phase high performance liquid chromatographic method for simultaneous estimation of dicyclomine hydrochloride, paracetamol, and mefenamic acid from multicomponent tablet dosage form. Methods: The optimized chromatographic separation was achieved using a stationary phase of hypersil gold ODS-C18 (250 × 4.6 mm i.d, 5 μm particle size) column and mobile phase of acetonitrile: Methanol: Potassium dihydrogen phosphate buffer, pH adjusted to 4.5 with orthophosphoric acid (OPA) in the ratio of 50: 30: 20 (v/v/v) with a flow rate of 1 mL/minute. The ultraviolet detection was carried out at 260 nm. Results: The retention times of paracetamol, dicyclomine hydrochloride and MEF were found to be 4.2, 6.1 and 3.4 minutes, respectively. The method was validated for linearity, precision, accuracy, and robustness. The developed method provided linear responses within the concentration ranges 2-12 µg/mL for dicyclomine hydrochloride, 50-300 µg/mL for paracetamol, and 25-150 µg/mL for MEF. The % recovery obtained were found to be 99.09-99.44% for dicyclomine hydrochloride, 99.22-99.51% for paracetamol, and 99.49-99.60 for MEF. Conclusion: The proposed method enables rapid quantification and simultaneous analysis of all the drugs from commercial formulations without any interference of excipients. Hence, the developed method can be successfully applied for routine analysis of dicyclomine hydrochloride, paracetamol, and MEF in their combined tablet formulation.

Pharmaceutical Drug Regulatory Affairs Journal

The medical device market in India is a sunrise sector in the pharmaceutical industry and has ach... more The medical device market in India is a sunrise sector in the pharmaceutical industry and has achieved a milestone in the last few years securing 4th position in the medical device market in Asia with increasing foreign direct investments through governments Make in India Campaign 2017, and PLI (Product linked incentive) schemes. To enter the medical device market in any country, one has to go through different procedures and regulatory requirements of that country. Medical devices are regulated in India by the DCGI (Drug Controller General of India) under the CDSCO (Central Drug Standard Control Organization). In China, the registration approval process is under NMPA (National Medical Product Administration) and requires complying with Chinese regulatory standard notice No. 218. Europe and Australian regulations are bit same and require a CE (Conformité Européenne) mark for manufacturing and marketing. U.S. regulations for approving medical devices are stringent and 510 (k) and PMA...

Objective: The present study was designed with an objective of a simple, fast, precise, selective... more Objective: The present study was designed with an objective of a simple, fast, precise, selective and accurate HPTLC method was developed and validated for the simultaneous determination of bisoprolol fumarate and hydrochlorothiazide from bulk and formulations. Methods: High performance thin layer chromatography (HPTLC) method was developed and validated for rapid analysis of simultaneous determination of bisoprolol fumarate and hydrochlorothiazide. Chromatographic separation was achieved on precoated silica gel HPTLC aluminum plate 60 F254 using ethyl acetate: methanol: ammonia 10:0.5:0.5 (v/v) as mobile phase. Detection was performed at 225 nm wavelength densitometrically. Results: The RF of bisoprolol fumarate and hydrochlorothiazide were 0.60 and 0.38, respectively. Linearity was observed in the concentration range of 150-900 ng/spot for bisoprolol fumarate and 100-600 ng/spot for hydrochlorothiazide. Percent recoveries obtained for both the drugs were 99.45 ± 0.06% for bisoprol...

Objective: To develop and subsequently validate a new simple and sensitive high performance thin ... more Objective: To develop and subsequently validate a new simple and sensitive high performance thin layer chromatographic (HPTLC) method for estimation of Levocetirizine, Pseudoephedrine and Ambroxol simultaneously, from a bulk drug and combined dosage form. Method: The separation of drugs was carried out on Merck HPTLC aluminium sheets of silica gel 60 F254 as stationary phase and the chromatogram was developed using Ethyl-acetate: methanol: ammonia (8: 1: 0.5 v/v/v) as the mobile phase. Result: Levocetirizine, Pseudoephedrine and Ambroxol showed Rf values 0.1 ± 0.02, 0.39 ± 0.05, and 0.73 ± 0.05 respectively, when scanned densitometrically at 212 nm using Camag TLC Scanner. The described method was linear over a concentration range of 100 ng spot-1 to 700 ng spot-1, 600 ng spot-1 to 4200 ng spot-1 and 1200 ng spot-1 to 8400 ng spot-1 for the Levocetirizine, Pseudoephedrine and Ambroxol respectively. Results of analysis were validated according to International Conference on Harmoniza...

Research Journal of Pharmacy and Technology, 2020

Indian Journal of Experimental Biology (IJEB), Sep 30, 2020

Loss of erythrocyte membrane deformability is one of the most crucial factors in developing compl... more Loss of erythrocyte membrane deformability is one of the most crucial factors in developing complications associated with Type II diabetes. The observed loss of erythrocyte membrane deformability could be related to structural changes in the membrane. In this context, here, we have made an attempt at gaining a better insight (quantitative as well as qualitative) into the protein and lipid contents in erythrocyte membranes and their interrelationships in Type II diabetes. Age matched control (n=12) and Type II diabetic subjects (n=22) were selected for this study. Morphological characteristics were studied by atomic force microscopy (AFM). AFM study confirmed remarkable alterations in morphology of the diabetic erythrocytes. In diabetic erythrocytes following changes were noted: (i) Significant increase in membrane as well as cytosolic proteins with a marginal increase in phospholipids content; (ii) The membrane total lipids:protein, phospholipids:protein, cholesterol:protein and phospholipids:cholesterol (mole:mole) ratios decreased significantly; (iii). A reproducible decrease in docosahexaenoic acid (DHA) and Omega-3 index with increase in Omega-6:Omega-3 ratio in membrane fatty acids; and (iv) The SDS-PAGE analysis indicated that all membrane proteins increased in almost equal proportion leading to increased membrane protein content. The observed compositional and stochiometric changes in lipids, proteins and their ratios may underlie morphological alterations and loss of deformability.

international journal of chemical sciences, 2008

A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic... more A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of racecadotril in bulk drug and its dosage form was developed and validated. The method employed Merck HPTLC aluminum sheets of silica gel 60F 254 as the stationary phase. The solvent system consisted of chloroform : methanol (9.8 : 0.2 v/v). This system was found to give compact spots for racecadotril (R f 0.61 ± 0.02). Racecadotril was subjected to acid and alkali hydrolysis, oxidation and photodegradation, and the degraded products were well separated from pure drug. Densitometric analysis of racecadotril was carried out in the remission-absorbance mode at 232 nm. The linear regression analysis data for the calibration plots showed good linear relationship with coefficient of regression value, r 2 = 0.9994 in the concentration range of 100-1000 ng per spot. The mean value of correlation coefficient, slope and intercept were 0.9995 ± 1.88, 0.352 ± 0.02 and 5.205 ± 0.05, respectively. The limits of detection and quantitation were 200 and 600 ng per spot, respectively. The method was validated as per ICH guidelines for precision, recovery and robustness. Racecadotril samples on being degraded with hydrogen peroxide showed additional peaks at R f 0.006 and 0.64 while the drug on being subjected to acidic and basic hydrolysis showed additional peaks at R f 0.50 and 0.18, respectively. This indicates that the drug is susceptible to acid-base hydrolysis degradation, oxidation and photochemical degradation. Statistical analysis proves that the method is reproducible and selective for the estimation of the said drug. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.

Journal of analytical and bioanalytical techniques, Oct 10, 2019

Asian Journal of Research in Chemistry, 2012

A rapid assay procedure have been developed for the determination of Nebivolol hydrochloride base... more A rapid assay procedure have been developed for the determination of Nebivolol hydrochloride based on application of oxidant to the spectrophotometry and high performance thin layer chromatography (HPTLC) have been developed for simultaneous determination of Nebivolol hydrochloride and Hydrochlorothiazide in a bulk drug and pharmaceutical formulation. In spectrophotometric method, Nebivolol Hydrochloride is treated with a known excess of cerium (IV) sulphate and the residual oxidant is determined by treating with a fixed amount of indigo carmine, and measuring the absorbance at 610 nm and Chromatographic separation was achieved on aluminum foil plates precoated with silica gel 60GF-254, with chloroform: toluene: methanol: ammonia (5:3:2:0.1, v/v/v/v) as mobile phase. Detection was performed densitometrically at 278 nm. The RF of Nebivolol and Hydrochlorothiazide were 0.30 and 0.42, respectively. In spectrophotometry, Beer's law is obeyed over concentration range of 2–10 μg/mL. T...

Herbal cosmetics also known as "natural cosmetics". with the beginning of the civilization, manki... more Herbal cosmetics also known as "natural cosmetics". with the beginning of the civilization, mankind had the magnetic dip towards impressing others with their looks. At the time, there were no fancy fairness creams or any cosmetic surgeries. The only thing they had was the knowledge of nature, compiled in the ayurveda. With the science of Ayurveda, several herbs and floras were used to make Ayurvedic cosmetics that really worked. Ayurvedic cosmetics not only beautified the skin but acted as the shield against any kind of external affects for the body. The aim of the present study is focused to formulate a stable cream containing different herbs. Herbal cosmetics are the preparations used to enhance the human appearance. Aegle Marmelos (bael fruit), Aloe barbadensis (Aloe vera leaves), Curcuma longa (Turmericrhizomes), Prunus dulcis (Almond oil), Cucumis Sativus (cucumber) were selected. This study was carried out to formulate a cream for the purpose of nourishing, lightening, antiwrinkle, moisturizer, wound healer and antimicrobial activity. This herbal formulation was characterised for its spreadibility, good consistency, pH, non greasy and for no evidence of creaming. The cream was in the form of O/W emulsion and there was no phase separation. Various evaluation studies were performed including stability test, patch test, microbial test, pH, irritation test, etc; which proved that the prepared herbal cream is safe and effective to use.

Letters in Drug Design & Discovery, Feb 1, 2022

Background: Thymidine Phosphorylase (TP) is an imperative target for cancer researchers. In the c... more Background: Thymidine Phosphorylase (TP) is an imperative target for cancer researchers. In the current research, quantitative structure-activity relationship (QSAR) models were demonstrated to identify new TP inhibitors. Objective: The main objective is to perform a QSAR study on a series of 19 derivatives of thiobarbituric acid and new molecules designed and dock to check potency and efficacy for anticancer activity. Methods: Multiple linear regression analysis (MLR) was used to establish a two-dimensional quantitative structure-activity relationship (2D-QSAR) with regression coefficient values of 0.9781, 0.9513, and 0.9819 for the training set (r2), leave-one-out (LOO) dependent internal regression (q2), and external test set regression (r2 _pred), respectively. Three-dimensional quantitative structure-activity relationship (3DQSAR) model, obtained by using the simulated annealing k nearest neighbour (SA-KNN) method (q2 = 0.7880). Newly designed molecules were subjected to docking studies with 7-deazaxanthine taken as standard. Results: Molecular modelling, structure-based drug design and docking study analysis were performed. The new chemical entities (NCE’s) designed, docked towards targeted receptor and show good results as compared to the standard 7-deazaxanthine. It was found that these molecules bind similar amino acid pocket regions as that of standard. Molecules bind at the active site of TP enzyme involving H bond interactions with shorter distances showed greater affinity. At last, the oral bioavailability and toxic effect were evaluated as absorption, distribution, metabolism, and elimination (ADME) studies by computational means of the Qikprop tool of Schrodinger. Conclusion: One of the most successful and fast-increasing methodologies is molecular modelling. It not only aids in the prediction of specific target compounds but also aids in the cost reduction of valuable substances. QSAR and docking study was performed, and most of the molecules have shown good dock scores. Based on these results, NCE’s for anticancer activity were successfully designed and analysed in this research work which will be helpful for effective drug synthesis with less toxicity in the future. Others: 2D QSAR model was generated by three methods, and the best one was selected for further study. NCEs were planned based on descriptors such as topological, electrostatic, steric, and hydrophobic substitutions around the core.

Letters in Drug Design & Discovery

Background: Thymidine Phosphorylase (TP) is an imperative target for cancer researchers. In the c... more Background: Thymidine Phosphorylase (TP) is an imperative target for cancer researchers. In the current research, quantitative structure-activity relationship (QSAR) models were demonstrated to identify new TP inhibitors. Objective: The main objective is to perform a QSAR study on a series of 19 derivatives of thiobarbituric acid and new molecules designed and dock to check potency and efficacy for anticancer activity. Methods: Multiple linear regression analysis (MLR) was used to establish a two-dimensional quantitative structure-activity relationship (2D-QSAR) with regression coefficient values of 0.9781, 0.9513, and 0.9819 for the training set (r2), leave-one-out (LOO) dependent internal regression (q2), and external test set regression (r2 _pred), respectively. Three-dimensional quantitative structure-activity relationship (3DQSAR) model, obtained by using the simulated annealing k nearest neighbour (SA-KNN) method (q2 = 0.7880). Newly designed molecules were subjected to dockin...

A simple, specific, accurate and precise HPTLC method for simultaneous estimation of paracetamol,... more A simple, specific, accurate and precise HPTLC method for simultaneous estimation of paracetamol, lornoxicam and chlorzoxazone as the bulk drug and in tablet dosage form. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of chloroform: toluene: methanol: glacial acetic acid 6: 3: 1: 0.04 (v/v/v/v). Densitometric evaluation of the separated zones was performed at 275 nm. The three drugs were satisfactorily resolved with RF values 0.26 ± 0.02, 0.45 ± 0.03 and 0.53 ± 0.01 for paracetamol, lornoxicam and chlorzoxazone respectively. The method can be used for estimation of combination of these drugs in tablets. The method was validated as per ICH guidelines. The linearity of developed method was achieved in the range of 10 – 50 ng/spot for each of paracetamol, lornoxicam and chlorzoxazone and recoveries from tablets were between 99.27 ± 0.70, 99.37 ± 0.06 and 99.10 ± 0.30 %. ...

Research presents simple, rapid and economical method for the simultaneous analysis estimation of... more Research presents simple, rapid and economical method for the simultaneous analysis estimation of both the drugs from pharmaceutical dosage form. MATERIALS AND METHODS Materials Paracetamol and Lornoxicam were obtained as a gift sample by Itros Pharmaceutical Ltd. Pune. Methanol (HPLC grade) was purchased from Merck Chemicals Limited, Mumbai. In-house double distilled water was used throughout the study. Fixed dose combination tablet (Lornsafe-plus) containing 500mg paracetamol and 8mg lornoxicam were procured from local market. Instrumentation The HPLC system consisted of Intelligent HPLC pump model (Jasco PU 2080 Plus) with sampler programmed at 20 μL capacity per injection was used. The detector consisted of a UV/ VIS (Jasco UV 2075 Plus). Data was integrated using Jasco Borwin version 1.5, LC-Net II/ADC system. ODS HyperSil C18 (250 mm, 4.6 mm, 5 μm) column was used, Japan. Preparation of standard and sample solutions The standard stock solution was prepared by transferring 10 mg of paracetamol and 10mg lornoxicam in a 10 mL volumetric flask. Add about 10 mL of mobile phase and sonicate to dissolve. Dilute 0.1mL of this solution to 10mL with Mobile phase and mix. Final standard concentration of paracetamol and lornoxicam is 10 μg/mL. Lornsafe-plus 20 intact tablets were accurately weighed to determine average weight of tablets. Then tablets were finely crushed and tablet powder equivalent to about 500mg of paracetamol and 8mg of lornoxicam was transferred into 100 mL volumetric flask. Then 60 mL methanol was added to flask and sonicated for 30 minutes with intermittent shaking. Make the volume up to mark with mobile phase ABSTRACT A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of paracetamol and lornoxicam from tablets by reverse phase C18 column ODS HyperSil (250 mm, 4.6 mm, 5 μm). The sample was analyzed using methanol: water (85:15, v/v), as a mobile phase at a flow rate of 1 mL/min. and detection at 259 nm. The retention time for paracetamol and lornoxicam was found to be 3.30 min and 2.14 min, respectively. The method can be used for estimation of combination of these drugs in tablets. The method was validated as per ICH guidelines. The linearity of developed method was achieved in the range of 0.4-1.4 μg/mL for paracetamol and 0.6-1.6 μg/ mL for lornoxicam and recoveries from tablets were between 100.36% and 100.17%. Due to these attributes, the proposed method could be used for routine quality control analysis of these drugs in combined dosage forms.

Indian drugs, 2003

A simple, specific and precise high performance thin layer chromatographic method has been develo... more A simple, specific and precise high performance thin layer chromatographic method has been developed for mosapride citrate in its tablet dosage form. In this method, standard solutions and sample solutions of Mosapride citrate were applied on precoated Silica gel G60 F 2 5 0 TLC plate and developed using a mixture of toluene: Methanol (80.20 V/V) as mobile phase. Quantification was carried out by the use of densitometer absorbance mode at 306 nm. This HPTLC system was quantitatively evaluated in terms of stability, precision, repeatability, specificity, accuracy and calibration proving the utility in the analysis of its tablet dosage forms.

A simple, selective, precise and stability-indicating high-performance thin layer chromatographic... more A simple, selective, precise and stability-indicating high-performance thin layer chromatographic method for analysis of bumetanide (BUM), both as the bulk drug and in a tablet formulation, has been developed and validated. Aluminium foil TLC plates precoated with silica gel 60F254 were used as stationary phase and toluene: ethyl acetate: formic acid (7: 3.5: 0.5, v/v/v) as mobile phase. A compact band (RF 0.45 ± 0.02) was obtained for BUM. Densitometric analysis was performed in absorbance mode at 335 nm. Linear regression analysis revealed a good linear relationship (r2 = 0.9996) between peak area and concentration in the range 100–800 ng/spot. The mean values ± RSD of the slope and intercept were 0.9987 ± 0.965 and 23.471 ± 1.24, respectively. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 30 and 80 ng/spot, respectively. BUM was subjected to acid and alkaline hydrolysis, oxidation, and photochemical and thermal deg...

High performance thin layer chromatographic method has been developed for the simultaneous determ... more High performance thin layer chromatographic method has been developed for the simultaneous determination of Propranolol hydrochloride and Hydrochlorothiazide from bulk and formulations. Chromatographic separation was achieved on aluminum foil plates precoated with silica gel 60F254, with chloroform: ethyl acetate: methanol 4: 4: 2 (v/v/v) as mobile phase. Detection was performed densitometrically at 274 nm. The Rf of Propranolol hydrochloride and Hydrochlorothiazide were 0.27± 0.02 and 0.56 ± 0.02, respectively. Parameters such as linearity, precision, accuracy, specificity and robustness are studied as reported in the ICH guidelines. Linearity was observed in the concentration range of 160-960 ng/band for Propranolol hydrochloride and 100-600 ng/band for Hydrochlorothiazide. The mean recoveries obtained for Propranolol hydrochloride and Hydrochlorothiazide were 99.63 % and 99.15 % respectively. Developed method was found to be accurate, precise, selective and rapid for simultaneous...

Micellar liquid chromatographic method has been developed for the simultaneous determination of P... more Micellar liquid chromatographic method has been developed for the simultaneous determination of Propranolol hydrochloride and Hydrochlorothiazide from bulk and formulations. Chromatographic separation achieved isocratically on ODS hypersil C18 column (5 μm, 250 mm × 4.6 mm) and micellar mobile phase of 0.07M sodium dodecyl sulfate (SDS) pH 3 adjusted with phosphate buffer and 15 % (v/v) 1- propanol as organic modifier in the ratio 70: 30 v/v and ultraviolet detection at 274 nm are used for the determination. In the developed method Propranolol hydrochloride and Hydrochlorothiazide elute at typical retention times of 6.767 min and 2.633 min, respectively at a 1 mL/min flow rate. Parameters such as linearity, precision, accuracy, specificity and robustness are studied as reported in the ICH guidelines. Linearity was observed in the concentration range of 4-24 μg/mL for Propranolol hydrochloride and and 2.5-15 μg/mL for Hydrochlorothiazide. The mean recoveries obtained for Propranolol ...