Charu Pandya - Academia.edu (original) (raw)

Papers by Charu Pandya

A simple, isocratic, specific and sensitive stability-indicating high-performance liquid chromato... more A simple, isocratic, specific and sensitive stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of fimasartan in synthetic mixture. Fimasartan is used to treat hypertension. Reverse phase chromatography was performed on Shimadzu LC-20AD pump (binary) and Shimadzu PDA-M20A Diode Array Detector using Hypersil BDS C18 column (250 x 4.6 mm, 5μm) mobile phase containing Phosphate buffer pH3 :Acetonitrile (50:50, v/v) with a flow rate of 1ml/min. Detection was done at wavelength 262nm. Linearity was observed in the concentration range of 5-30μg/mL (R2=0.999) with regression equation y=78487x+66095. The LOD was found to be 1.54μg/ml and LOQ was found to be 4.67μg/ml. Fimasartan was subjected to stress conditions such as acidic, alkaline, oxidation, photolysis and thermal degradations. The proposed method was validated as per ICH guideline and was found to be accurate, precise and specific. The degradation products peaks were well resolved from the standard drug peak and hence this method can be used for quality control of fimasartan. The drug showed significant degradation in alkaline and oxidative condition. Degradation products in alkaline and oxidative conditions were identified by LC-MS. Oxidative degradation followed first order kinetic. Degradation rate constants and half -lives were determined.

International research journal of pharmacy, Apr 23, 2019

In the stress degradation studies of Acotiamide, two degradation products in alkaline conditions ... more In the stress degradation studies of Acotiamide, two degradation products in alkaline conditions were identified by LC-MS. These impurities were isolated using preparative high performance liquid chromatography. By spectral data analysis (1 H NMR, 13 C NMR, MS, and IR), degradation products are characterized as 2-hydroxy-4,5-dimethoxy benzoic acid, and 2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]-1,3-thiazole-4-carboxylic acid. The details of stress studies, identification, isolation, characterization, formation and mechanism of degradation products are discussed and presented here.

International Journal of Pharmacy and Pharmaceutical Sciences, Jun 1, 2018

Objective: To develop and validate stability indicating HPTLC method for determination of clevidi... more Objective: To develop and validate stability indicating HPTLC method for determination of clevidipine butyrate in synthetic mixture. Methods: The present study deals with development and validation of stability indicating HPTLC method for estimation of clevidipine butryate. Chromatographic separation was performed on aluminum plate pre coated with Silica Gel 60 F254 using toluene: ethyl acetate (8:2) as mobile phase. TLC scanner was set at wavelength of 370 nm. Results: Retention factor Rf Conclusion: A new, Simple, Accurate, Precise, Sensitive and economic stability indicating HPTLC method has been developed and validated for the determination of clevidipine and can be employed for stability indicating analysis. of clevidipine was found to be 0.49. The method was validated as per ICH guidelines. Calibration curve was in the range of 1000-6000ng/band. The correlation coefficient was found to be 0.999. The precision expressed by RSD was less than 2%. The accuracy of method was confirmed by recovery studies using standard addition method and recovery was found to be 99.03-99.57%. The drug was subjected to ICH prescribed hydrolytic, oxidative, photolytic and thermal stress conditions. Clevidipine and its degradation products were well resolved under experimental conditions. The method was validated according to ICH guidelines. The drug showed significant degradation in alkaline and acidic condition and slight degradation in oxidative condition. The drug was stable in thermal condition.

Indian Drugs

Capillary electrophoresis is a rapid, flexible and effective separation technique with minimum re... more Capillary electrophoresis is a rapid, flexible and effective separation technique with minimum requirement of sample and chemicals. This article focuses on recent advances in capillary electrophoresis, covering various preconcentration techniques, methods, injection techniques, detection techniques and applications of capillary electrophoresis in various fields.

Indian Journal of Pharmaceutical Education and Research, 2021

Background: A validated high performance planar chromatographic analysis for a combination medica... more Background: A validated high performance planar chromatographic analysis for a combination medication of corticosteroids mometasone furoate and bronchodilators formoterol fumarate available as Evocort®: inhaler in market was developed. It is used for treating asthma, a reversible obstructive airways disease. Materials and Methods: The HPTLC chromatographic condition was optimised using aluminium sheets formerly coated with silica gel 60F254 as stationary phase and toluene: methyl alcohol: methanoic acid (12.5:4:0.3 v/v/v) as mobile phase. Results: Formoterol fumarate and mometasone furoate concentration was found to be directly proportional to peak area in the range of 120-720 ng/band and 3996-23976 ng/band, respectively. Results of precision studies were between 0.77-1.274 stated in %RSD and recovery studies ranged from 99101% indicating very low inter day variability and good reproducibility of the method. Fractional factor design was applied to five factors i.e. volume of mobile ...

Objective: The objective of present work was to develop and validate simple, precise, accurate an... more Objective: The objective of present work was to develop and validate simple, precise, accurate and specific stability indicating method for determination of acotiamide in presence of its degradation products. Methods: An isocratic RP-HPLC method has been developed using C-8 Thermo Hypersil BDS Column (250 x 4.6 mm i.d., 5µparticle size) with the mobile phase composition of acetonitrile: 0.1 % triethylamine in 0.2% formic acid (30: 70) at column oven temperature of 40 °C. The flow rate was 1.0 ml min -1 and effluent was detected at 282 nm. The method was validated in terms of linearity, accuracy, precision, LOD (Limit of Detection), LOQ (Limit of Quantification) and robustness as per ICH guidelines. Results: The method was found to be linear in the range of 10-60µg/ml. Limit of detection and limit of quantification was found to 0.36µg/ml and 1.10 µg/ml.% Recovery was found to be in the range of 99.45%-99.75%and precision less than 2%. The developed method was successfully applied for...

The present work includes a simple, rapid, accurate and precise isocratic RP-HPLC method for est... more The present work includes a simple, rapid, accurate and precise isocratic RP-HPLC method for estimation of besifloxacin hydrochloride in bulk and its formulation. The simple, isocratic RP-HPLC method involves separation of besifloxacin hydrochloride on reverse phase C8 oyster column (250 mm x 4.6 mm, 5 µm ) with a mobile phase of phosphate buffer (pH 3) :methanol: acetonitrile (50:25:25 %v/v/v). The developed methods were validated successfully according to ICH Q2 (R1) guidelines. The method showed a good linear response with r 2 values of 0.999 . The percentage relative standard deviation for the method was found to be less than two, indicating the method is precise. The mean percentage recovery for RP-HPLC method was between 98.34%-101.56% . Besifloxacin hydrochloride in its opthalamic formulation could be accurately determined with assay value of 98.97%. The developed method is specific, selective and robust. The method could be successfully applied for analysis of optha...

Journal of Applied Pharmaceutical Science, Apr 1, 2020

Efonidipine HCl Ethanolate is an antihypertensive drug with 1,4 dihydropyridine and phosphinane d... more Efonidipine HCl Ethanolate is an antihypertensive drug with 1,4 dihydropyridine and phosphinane derivative. Forced degradation study was performed in Efonidipine as per the guidelines by International Conference on Harmonization (ICH) Q1A (R2). Extensive degradation and slight degradation were observed in alkaline and photolytic conditions, respectively, whereas acidic, oxidative, and thermal conditions did not show any degradation. Degradation products were separated on Thermo Hypersil BDS C18 column (250 × 4.6 mm, 5 µ), mobile phase in gradient mode using ammonium acetate buffer and acetonitrile with detection at a wavelength of 254 nm. Six degradation products in alkaline condition and four degradation products in photolytic condition were identified by HPLC and characterized by mass spectrometry using LC-Q-TOF-MS, and degradation pathway was proposed. This is the typical case of degradation, where co-solvent methanol reacts with Efonidipine to form pseudo degradation products such as DP1, DP4, DP5, and DP6. Three degradation products DP1, DP3, and DP4 in alkaline condition were isolated by preparative HPLC and were characterized by LC-Q-TOF-MS, 1 H/ 13 C NMR, and IR techniques. By characterization with these techniques, DP1 is characterized as 3-2-(N-benzylanilino)ethyl 3-oxo-2,2-dimethylpropyl hydrogen 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl) pyridin-3-yl-3-phosphonate, DP3 is characterized as 2-(N-benzyl-N-phenylamino) ethanol, and DP4 is characterized as 3-methoxy-2,2-dimethylpropyl hydrogen 1,4-dihydro-2,6-dimethyl-5-methyloxycarbonyl-4-(3nitro)phenylpyridin-3-yl-3-phosphonate. The developed method was validated as per guidelines by ICH with respect to linearity, accuracy, precision, limit of detection, and robustness.

Rasayan Journal of Chemistry

In the stress degradation studies of Fimasartan, one major unknown oxidative degradation impurity... more In the stress degradation studies of Fimasartan, one major unknown oxidative degradation impurity was identified by LC-MS. This impurity was separated by preparative HPLC. By spectral data analysis (1 H NMR, 13 C NMR, DEPT, MS/MS and IR), this impurity is characterized as 2-(1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-butyl-1,6-dihydro-4-methyl-6-oxo-pyrimidin-5-yl)-N,N-dimethylacetamide. The details of stress studies, identification, isolation, characterization, formation and mechanism of this impurity are discussed and presented here.

Indian Journal of Pharmaceutical Education and Research

Aim: The present study reports the degradation behavior of new antihypertensive drug Riociguat un... more Aim: The present study reports the degradation behavior of new antihypertensive drug Riociguat under various stress conditions as per International Conference on Harmonization guidelines ICH, Q2(R1). Materials and Methods: Riociguat was subjected to stress degradation under hydrolytic (acidic, alkaline and neutral), oxidative, photolytic and thermal stress conditions to investigate the inherent stability. A rapid, accurate, precise and robust HPLC method was developed on Waters Symmetry C 18 Column (150mm X 4.6 mm, 5µ) using isocratic elution of 10 mm ammonium acetate buffer pH 5.7 and acetonitrile in the ratio of 70:30 with the flow rate at 1.0 mL/min.The detection was performed at 254nm. Results: The drug was found to be degraded in alkaline and oxidative condition whereas it was stable under acidic, neutral hydrolytic, thermal and photolytic conditions. Two degradation products (DP1, DP2) under alkaline condition and one under oxidative condition (DP3) were characterized by LC-HR-MS/MS with accurate mass measurements. Degradation products (DP1, DP2 and DP3) were isolated by preparative HPLC and were characterized by 1 H NMR, 13 C NMR, APT and IR Techniques. Conclusion: Using spectral data analysis, alkaline degradation product DP1 wascharacterized as 2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-N5-methylpyrimidine-4,5,6-triamine and DP2 was characterized as 2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-6-amino-7-methyl-7H-purin-8(9H)-one while oxidative degradation product DP3was characterized as methyl 2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-4,6diaminopyrimidin-5-ylmethylcarbamate-N-oxide.The developed chromatographic method was validated in terms of specificity, linearity, accuracy, precision as per ICH guidelines. The robustness of the method was studied with 2-level fractional factorial design 2^4-1 .