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Papers by Rinchi bora

International journal of pharmaceutical quality assurance, Mar 25, 2020

The QRM or Enablers are a fundamental feature of the regulatory bodies for a quality product. In ... more The QRM or Enablers are a fundamental feature of the regulatory bodies for a quality product. In the US, during the Mexican-American War of 1846-1848, many deaths occurred. The reason was not a slaughter scene in wartime only, but also due to a lack of safety and efficacy of imported drugs. The United States Import Drug Act 1848 was authorized for testing and assuring the safety and purity of imported drugs before crossing the border. The modern finding of risk management for drug and biological products arose with a 1999 risk management report to the Food and Drug Administration (FDA) Commissioner by Task Force. A conception for proactive risk management including internal Risk and external Risk was approved in August 2002 with the declaration of a new Food and Drug Administration proposal entitled "Pharmaceutical cGMPs for the 21 st Century-A Risk-based approach". In September 2004, the conclusive report on the FDA proposal emerged. The report foretold that industry and FDA should adopt the quality systems model for quality management and regulations. 1 The olden ways to assure quality in product and process are Trends review, Changes review, Flow charts, Checklists, Observation compilations (Complaints, Deviations, etc.). Now quality risk management ground rules are implemented across the industry with the help of predictable QRM or Enabler tools hold up with statistical tools. THE QUALITY RISK MANAGEMENT ICH states that "Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risk to the quality of the medicinal product across the product lifecycle. 3 The entire ICH-Q9 guideline is devoted to quality risk management as QRM or enablers play an important role in producing a quality product. QRM or Enablers ascertain that the quality risk evaluation is based on customary comprehension, absolute process awareness, and eventually keeping patients safe. QRM or Enablers could be a proactive or retrospective strategy. TOPICS ENCLOSED BY ENABLERS OR QRM • Praxis of risk analysis, QMS risk, and risk of CAPA systems. • Praxis of risk assessment for product-market complaints monitoring. • Praxis of risk analysis in pharmaceutical manufacturing compliance and audit. • Praxis of risk principles to actuate or bring into operation, product qualification, and product validation. • Quality risk management master plan advancement. • Hazard analysis and critical control point (haccp) in manufacturing and operation monitoring. • ICH Q9-Pharmaceutical quality risk management.

Research Journal of Pharmacy and Technology, 2019

The drug analysis theatres a very dynamic role in the drug development, manufacturing and therape... more The drug analysis theatres a very dynamic role in the drug development, manufacturing and therapeutic use. The pharmaceutical industries mainly rely on the quantitative analysis to ensure that those raw materials and the final product obtained meets the essential specifications. The day by the new molecules or new formulation are increasing either a new entities or a synthetic form. There is even much more increasing the number of impurities in the drugs moieties. Now a days not just only purity profile but also impurity profile is also become a further popular as per various regulatory body like International conference on harmonization (ICH), Therapeutic good administration (TGA), US food and drug administration (USFDA). Rosiglitazone is an antidiabetic drug and thiazolidinedione class. The 2, 4 TD is the basic reactant impurity in the Rosiglitazone drug. The analytical method HPLC is to separate compounds that are dissolved in solution. In this experiment the separation was carried out on Phenomenex® C18 (250 x 4.6 mm i.d., 5μ), Column having particle size 5 μ using water and Acetonitrile in ratio of 50: 50 in gradient mode at the flow rate of 1 ml/minute. And the wavelength of the detection was 288 nm. The retention time for Rosiglitazone and 2, 4Thiazolidinedione was 4.942min and 3.092min respectively. Analytical validation parameter such as selectively, specificity, linearity, accuracy and precision were evaluated. The assay studies were carried out 6 times and the percentage relative standard deviation (%RSD) of the percentage recovery were calculated and presented in table for Rosiglitazone and 2, 4 Thiazolidinedione. from the data obtained, the amount of Rosiglitazone were found 99.12% to 99.32% w/w in the bulk drug and marketed formulation respectively. The 2, 4Thiazolidinedione were present 0.7821 μg/gm and 0.6531 μg/gm in the bulk drug and formulation respectively. Thus, the developed RP-HPLC method was found to be suitable for the estimation of impurities in Rosiglitazone.

Journal of Young Pharmacists, Sep 15, 2021

Papain a proteolytic enzyme is one of the enzymes which have various applications in regard to th... more Papain a proteolytic enzyme is one of the enzymes which have various applications in regard to the food and chemical industry. Papain is isolated by cutting or making incision on the unripe fruit of papaya. Papain enzyme is more active in unripe green fruit. Papaya contains a papain enzyme which will be more helpful in treating the causes of trauma, allergies and sports injuries also papain has a superior digestion action when compare to pepsin and pancreatin. Papain is used variously in textile, pharmaceutics and cosmetics. The papain is extracted from the latex of papaya which is a major chemical compound used in various industries for numerous pharmaceutical and industrial products. Researchers interest towards the enzymes including papain enzyme and it health benefits is favorable. Fusion of papain in various food systems, it has its own stability issues which concerns in deactivate or denature of papain enzyme when it comes in contact with acidic pH inside the body. Several mechanical and chemical processes based on encapsulation techniques have emerged that have been tailored to suit the encapsulation of various food bioactive compounds. Therefore, in order to protect the nature of papain enzyme, Encapsulation/ Formulation has been proposed as an option. After the Encapsulation/ Formulation is done the enzyme will improves its stability issues, maximum therapeutic potential, and also helps in the oral bioavailability and effective oral delivery of the Papain enzyme.

Current Drug Discovery Technologies, Mar 29, 2021

Background: CCR5 and/or CXCR4 receptors on CD4+ T cell membranes are the active sites for HIV to ... more Background: CCR5 and/or CXCR4 receptors on CD4+ T cell membranes are the active sites for HIV to bind. The different classes of drugs have a unique mechanism of action to cease the virus, but we are concentrating in the first-class i.e. NNRTI that destroys the virus while it binds to the cell surface gp120 protein. The drugs are having several impurities that can be genotoxic and few are reported in the monographs. Objective: This study proposes the affinity of the impurities to the active site through molecular docking to a receptor (PDB ID 4MBS) from the library of analogs available for antiretroviral drugs. As these drugs are taken for the long term, this study will give a prominent idea for testing the impurities and their genotoxicity. Method: We have done molecular docking of 37 impurities and drugs with the GLIDE module of schrodinger software for their binding affinities. In this study, receptor CCR5 and/or CXCR4 is selected containing glycoprotein that mediates virus binding to CD4+ T cell. Results: Didanosine E and Zidovudine D shows maximum and minimum score respectively. The selected impurities were interfering with the active binding site that may lead to any ADR or reduce the effect of API. Conclusion: Conclusively, a significant role is played by Protein-Ligand interaction in structuralbased designing. Summarizing that there might be a genotoxicity effect due to competition between API and the impurities. The molecular docking was used to study the binding mechanism and to establish the docking score along with the activity. The outcome of the study can be used to design and development of novel compounds having genotoxicity.

Turkish Online Journal of Qualitative Inquiry, Oct 16, 2021

Research Journal of Pharmacy and Technology, 2019

The drug analysis theatres a very dynamic role in the drug development, manufacturing and therape... more The drug analysis theatres a very dynamic role in the drug development, manufacturing and therapeutic use. The pharmaceutical industries mainly rely on the quantitative analysis to ensure that those raw materials and the final product obtained meets the essential specifications. The day by the new molecules or new formulation are increasing either a new entities or a synthetic form. There is even much more increasing the number of impurities in the drugs moieties. Now a days not just only purity profile but also impurity profile is also become a further popular as per various regulatory body like International conference on harmonization (ICH), Therapeutic good administration (TGA), US food and drug administration (USFDA). Rosiglitazone is an antidiabetic drug and thiazolidinedione class. The 2, 4 TD is the basic reactant impurity in the Rosiglitazone drug. The analytical method HPLC is to separate compounds that are dissolved in solution. In this experiment the separation was carri...

Journal of Young Pharmacists, 2021

Papain a proteolytic enzyme is one of the enzymes which have various applications in regard to th... more Papain a proteolytic enzyme is one of the enzymes which have various applications in regard to the food and chemical industry. Papain is isolated by cutting or making incision on the unripe fruit of papaya. Papain enzyme is more active in unripe green fruit. Papaya contains a papain enzyme which will be more helpful in treating the causes of trauma, allergies and sports injuries also papain has a superior digestion action when compare to pepsin and pancreatin. Papain is used variously in textile, pharmaceutics and cosmetics. The papain is extracted from the latex of papaya which is a major chemical compound used in various industries for numerous pharmaceutical and industrial products. Researchers interest towards the enzymes including papain enzyme and it health benefits is favorable. Fusion of papain in various food systems, it has its own stability issues which concerns in deactivate or denature of papain enzyme when it comes in contact with acidic pH inside the body. Several mechanical and chemical processes based on encapsulation techniques have emerged that have been tailored to suit the encapsulation of various food bioactive compounds. Therefore, in order to protect the nature of papain enzyme, Encapsulation/ Formulation has been proposed as an option. After the Encapsulation/ Formulation is done the enzyme will improves its stability issues, maximum therapeutic potential, and also helps in the oral bioavailability and effective oral delivery of the Papain enzyme.

Rinchi Bora, Hemkumar B., Ramesh J., Rupika Sunidhi C, Jeyaprakash M. R*., Ashish Wadhwani Abstra... more Rinchi Bora, Hemkumar B., Ramesh J., Rupika Sunidhi C, Jeyaprakash M. R*., Ashish Wadhwani Abstract-Benzalkonium chloride is a quaternary ammonium compound, widely used as a preservative in toiletry preparations. Literature review reveals that the safety evaluation of the said preservative has not been focused on; hence this study aims to develop a complete safety profile based on the estimated quantity present in the marketed toiletry products. The safety study is developedbased on in vitro genotoxicity model. The AMES kit was used for the genotoxicity assessment. Quantification of the preservative was done using UV-visible spectrophotometry. The estimation was performed at 262.5 nm as λmax. The method was linear from 0.1 to 0.9μg /ml with R 2 value of 0.9967. Solubility studies show that BKC is freely soluble inwater and ethanol,andsparingly soluble in acetone. The genotoxicity study results express that the preservative possesses mutagenic effect. Key wordsBenzalkonium chloride, ...

Current Drug Discovery Technologies, 2022

Background: CCR5 and/or CXCR4 receptors on CD4+ T cell membranes are the active sites for HIV to ... more Background: CCR5 and/or CXCR4 receptors on CD4+ T cell membranes are the active sites for HIV to bind. The different classes of drugs have a unique mechanism of action to cease the virus, but we are concentrating in the first-class i.e. NNRTI that destroys the virus while it binds to the cell surface gp120 protein. The drugs are having several impurities that can be genotoxic and few are reported in the monographs. Objective: This study proposes the affinity of the impurities to the active site through molecular docking to a receptor (PDB ID 4MBS) from the library of analogs available for antiretroviral drugs. As these drugs are taken for the long term, this study will give a prominent idea for testing the impurities and their genotoxicity. Method: We have done molecular docking of 37 impurities and drugs with the GLIDE module of schrodinger software for their binding affinities. In this study, receptor CCR5 and/or CXCR4 is selected containing glycoprotein that mediates virus bindin...

INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE, 2013

Risk is intertwined with every drug product in a market. This article’s intent is to provide grou... more Risk is intertwined with every drug product in a market. This article’s intent is to provide ground rule and praxis of different tools for quality risk management (QRM) in various aspects of pharmaceutical science. QRM comprises of tools and processes which helps in establishing objectives. Hence they are also known as Enablers. Enablers help in risk mitigation of product quality throughout a lifecycle in such a way that benefit outweighs the risk. The key properties of Enablers or QRM, i.e., attempts made, solemnness and records shall be compatible with risk scale. The Enablers accomplishment gives recognized, obvious and steps of Enabler process produced by regeneratable methods which is based on customary comprehension to evaluate feasibility, ability to find out risk prejudice. The QRM or Enabler tools can assist the manufacturing company and regulatory bodies to scrutinize, handle, notify, and inspect the risk.

Journal of Young Pharmacists, 2019

Objective: In the pharmaceutical analytical field, effort to analyzing the degradation or related... more Objective: In the pharmaceutical analytical field, effort to analyzing the degradation or related and impurity substances from the complex matrix in the ultra-trace levels is a really a challengeable task. Impurity is any component of the new drug substance that is not the chemical entity defined as the new drug substance. Gemcitabine hydrochloride is a new anticancer bio molecule. According to Indian Pharmacopoeia there is two impurities present in this drug. The literature review exploded that, there is no specific impurity profiling based analytical method developed to estimate the Cytosine. Methods: RP HPLC is developed to quantify and separate Gemcitabine hydrochloride and Cytosine. The Hibar® C 18 (250 x 4.6 mm i.d., 5μ), Column choices as stationary phase, tri ethyl ether and Acetonitrile in ratio of 95:5 with 4.35 (with Orthophosphoric acid) as mobile phase, the flow rate fixed as 1ml/ min. at 279 nm. Results: A retention time found to be 3.44min and 8.28min for gemcitabine and cytosine respectively. The developed method was validated as per ICH guidelines and the method was proved as selective, specific and linear. The assay and recovery studies were carried out the assay limit was 99.19 and 99.32 for bulk drug and formulations respectively. The Cytosine were present 0.7821 µg/ml and 0.6531 µg/ml in the bulk drug and formulation respectively. Conclusion: It can be concluded that the developed RP-HPLC method was found to be suitable for the appraisal of cytosine impurities in Gemcitabine HCl. The developed RP-HPLC is economic and suitable for the use.

Journal of Applied Pharmaceutical Science, 2018

A sensitive LC-MS/MS method has been developed and validated for the quantitative determination o... more A sensitive LC-MS/MS method has been developed and validated for the quantitative determination of Dexlansoprazole from the commercially available formulations. Omeprazole was used as the internal standard. Isocratic separation was achieved using Zorbax SB C 18 column (4.6 × 100 mm, 3 µm) as a stationary phase and the mobile phase consists of (0.5 mM) Ammonium Acetate adjusted to pH 3.5: acetonitrile (30:70 V/V) with a flow of 0.5 mL/min. Detection was carried out by triple quadrupole mass spectrometry with electrospray ionization in positive mode with proton adducts at m/z 370.05 to 251.95 and 346.00 to 198.05 to monitor Dexlansoprazole and Omeprazole. The linearity of the method was found over a concentration range of 0.5-3000 ng/mL with a regression analysis of 0.9994. The percentage recovery of the present method was found to be 94.33 to 99.97%. The LC-MS/MS method was validated as per ICH guidelines. The developed method can be successfully applied for the estimation of Dexlansoprazole in the commercial formulation and in bulk drug.

International journal of pharmaceutical quality assurance, Mar 25, 2020

The QRM or Enablers are a fundamental feature of the regulatory bodies for a quality product. In ... more The QRM or Enablers are a fundamental feature of the regulatory bodies for a quality product. In the US, during the Mexican-American War of 1846-1848, many deaths occurred. The reason was not a slaughter scene in wartime only, but also due to a lack of safety and efficacy of imported drugs. The United States Import Drug Act 1848 was authorized for testing and assuring the safety and purity of imported drugs before crossing the border. The modern finding of risk management for drug and biological products arose with a 1999 risk management report to the Food and Drug Administration (FDA) Commissioner by Task Force. A conception for proactive risk management including internal Risk and external Risk was approved in August 2002 with the declaration of a new Food and Drug Administration proposal entitled "Pharmaceutical cGMPs for the 21 st Century-A Risk-based approach". In September 2004, the conclusive report on the FDA proposal emerged. The report foretold that industry and FDA should adopt the quality systems model for quality management and regulations. 1 The olden ways to assure quality in product and process are Trends review, Changes review, Flow charts, Checklists, Observation compilations (Complaints, Deviations, etc.). Now quality risk management ground rules are implemented across the industry with the help of predictable QRM or Enabler tools hold up with statistical tools. THE QUALITY RISK MANAGEMENT ICH states that "Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risk to the quality of the medicinal product across the product lifecycle. 3 The entire ICH-Q9 guideline is devoted to quality risk management as QRM or enablers play an important role in producing a quality product. QRM or Enablers ascertain that the quality risk evaluation is based on customary comprehension, absolute process awareness, and eventually keeping patients safe. QRM or Enablers could be a proactive or retrospective strategy. TOPICS ENCLOSED BY ENABLERS OR QRM • Praxis of risk analysis, QMS risk, and risk of CAPA systems. • Praxis of risk assessment for product-market complaints monitoring. • Praxis of risk analysis in pharmaceutical manufacturing compliance and audit. • Praxis of risk principles to actuate or bring into operation, product qualification, and product validation. • Quality risk management master plan advancement. • Hazard analysis and critical control point (haccp) in manufacturing and operation monitoring. • ICH Q9-Pharmaceutical quality risk management.

Research Journal of Pharmacy and Technology, 2019

The drug analysis theatres a very dynamic role in the drug development, manufacturing and therape... more The drug analysis theatres a very dynamic role in the drug development, manufacturing and therapeutic use. The pharmaceutical industries mainly rely on the quantitative analysis to ensure that those raw materials and the final product obtained meets the essential specifications. The day by the new molecules or new formulation are increasing either a new entities or a synthetic form. There is even much more increasing the number of impurities in the drugs moieties. Now a days not just only purity profile but also impurity profile is also become a further popular as per various regulatory body like International conference on harmonization (ICH), Therapeutic good administration (TGA), US food and drug administration (USFDA). Rosiglitazone is an antidiabetic drug and thiazolidinedione class. The 2, 4 TD is the basic reactant impurity in the Rosiglitazone drug. The analytical method HPLC is to separate compounds that are dissolved in solution. In this experiment the separation was carried out on Phenomenex® C18 (250 x 4.6 mm i.d., 5μ), Column having particle size 5 μ using water and Acetonitrile in ratio of 50: 50 in gradient mode at the flow rate of 1 ml/minute. And the wavelength of the detection was 288 nm. The retention time for Rosiglitazone and 2, 4Thiazolidinedione was 4.942min and 3.092min respectively. Analytical validation parameter such as selectively, specificity, linearity, accuracy and precision were evaluated. The assay studies were carried out 6 times and the percentage relative standard deviation (%RSD) of the percentage recovery were calculated and presented in table for Rosiglitazone and 2, 4 Thiazolidinedione. from the data obtained, the amount of Rosiglitazone were found 99.12% to 99.32% w/w in the bulk drug and marketed formulation respectively. The 2, 4Thiazolidinedione were present 0.7821 μg/gm and 0.6531 μg/gm in the bulk drug and formulation respectively. Thus, the developed RP-HPLC method was found to be suitable for the estimation of impurities in Rosiglitazone.

Journal of Young Pharmacists, Sep 15, 2021

Papain a proteolytic enzyme is one of the enzymes which have various applications in regard to th... more Papain a proteolytic enzyme is one of the enzymes which have various applications in regard to the food and chemical industry. Papain is isolated by cutting or making incision on the unripe fruit of papaya. Papain enzyme is more active in unripe green fruit. Papaya contains a papain enzyme which will be more helpful in treating the causes of trauma, allergies and sports injuries also papain has a superior digestion action when compare to pepsin and pancreatin. Papain is used variously in textile, pharmaceutics and cosmetics. The papain is extracted from the latex of papaya which is a major chemical compound used in various industries for numerous pharmaceutical and industrial products. Researchers interest towards the enzymes including papain enzyme and it health benefits is favorable. Fusion of papain in various food systems, it has its own stability issues which concerns in deactivate or denature of papain enzyme when it comes in contact with acidic pH inside the body. Several mechanical and chemical processes based on encapsulation techniques have emerged that have been tailored to suit the encapsulation of various food bioactive compounds. Therefore, in order to protect the nature of papain enzyme, Encapsulation/ Formulation has been proposed as an option. After the Encapsulation/ Formulation is done the enzyme will improves its stability issues, maximum therapeutic potential, and also helps in the oral bioavailability and effective oral delivery of the Papain enzyme.

Current Drug Discovery Technologies, Mar 29, 2021

Background: CCR5 and/or CXCR4 receptors on CD4+ T cell membranes are the active sites for HIV to ... more Background: CCR5 and/or CXCR4 receptors on CD4+ T cell membranes are the active sites for HIV to bind. The different classes of drugs have a unique mechanism of action to cease the virus, but we are concentrating in the first-class i.e. NNRTI that destroys the virus while it binds to the cell surface gp120 protein. The drugs are having several impurities that can be genotoxic and few are reported in the monographs. Objective: This study proposes the affinity of the impurities to the active site through molecular docking to a receptor (PDB ID 4MBS) from the library of analogs available for antiretroviral drugs. As these drugs are taken for the long term, this study will give a prominent idea for testing the impurities and their genotoxicity. Method: We have done molecular docking of 37 impurities and drugs with the GLIDE module of schrodinger software for their binding affinities. In this study, receptor CCR5 and/or CXCR4 is selected containing glycoprotein that mediates virus binding to CD4+ T cell. Results: Didanosine E and Zidovudine D shows maximum and minimum score respectively. The selected impurities were interfering with the active binding site that may lead to any ADR or reduce the effect of API. Conclusion: Conclusively, a significant role is played by Protein-Ligand interaction in structuralbased designing. Summarizing that there might be a genotoxicity effect due to competition between API and the impurities. The molecular docking was used to study the binding mechanism and to establish the docking score along with the activity. The outcome of the study can be used to design and development of novel compounds having genotoxicity.

Turkish Online Journal of Qualitative Inquiry, Oct 16, 2021

Research Journal of Pharmacy and Technology, 2019

The drug analysis theatres a very dynamic role in the drug development, manufacturing and therape... more The drug analysis theatres a very dynamic role in the drug development, manufacturing and therapeutic use. The pharmaceutical industries mainly rely on the quantitative analysis to ensure that those raw materials and the final product obtained meets the essential specifications. The day by the new molecules or new formulation are increasing either a new entities or a synthetic form. There is even much more increasing the number of impurities in the drugs moieties. Now a days not just only purity profile but also impurity profile is also become a further popular as per various regulatory body like International conference on harmonization (ICH), Therapeutic good administration (TGA), US food and drug administration (USFDA). Rosiglitazone is an antidiabetic drug and thiazolidinedione class. The 2, 4 TD is the basic reactant impurity in the Rosiglitazone drug. The analytical method HPLC is to separate compounds that are dissolved in solution. In this experiment the separation was carri...

Journal of Young Pharmacists, 2021

Papain a proteolytic enzyme is one of the enzymes which have various applications in regard to th... more Papain a proteolytic enzyme is one of the enzymes which have various applications in regard to the food and chemical industry. Papain is isolated by cutting or making incision on the unripe fruit of papaya. Papain enzyme is more active in unripe green fruit. Papaya contains a papain enzyme which will be more helpful in treating the causes of trauma, allergies and sports injuries also papain has a superior digestion action when compare to pepsin and pancreatin. Papain is used variously in textile, pharmaceutics and cosmetics. The papain is extracted from the latex of papaya which is a major chemical compound used in various industries for numerous pharmaceutical and industrial products. Researchers interest towards the enzymes including papain enzyme and it health benefits is favorable. Fusion of papain in various food systems, it has its own stability issues which concerns in deactivate or denature of papain enzyme when it comes in contact with acidic pH inside the body. Several mechanical and chemical processes based on encapsulation techniques have emerged that have been tailored to suit the encapsulation of various food bioactive compounds. Therefore, in order to protect the nature of papain enzyme, Encapsulation/ Formulation has been proposed as an option. After the Encapsulation/ Formulation is done the enzyme will improves its stability issues, maximum therapeutic potential, and also helps in the oral bioavailability and effective oral delivery of the Papain enzyme.

Rinchi Bora, Hemkumar B., Ramesh J., Rupika Sunidhi C, Jeyaprakash M. R*., Ashish Wadhwani Abstra... more Rinchi Bora, Hemkumar B., Ramesh J., Rupika Sunidhi C, Jeyaprakash M. R*., Ashish Wadhwani Abstract-Benzalkonium chloride is a quaternary ammonium compound, widely used as a preservative in toiletry preparations. Literature review reveals that the safety evaluation of the said preservative has not been focused on; hence this study aims to develop a complete safety profile based on the estimated quantity present in the marketed toiletry products. The safety study is developedbased on in vitro genotoxicity model. The AMES kit was used for the genotoxicity assessment. Quantification of the preservative was done using UV-visible spectrophotometry. The estimation was performed at 262.5 nm as λmax. The method was linear from 0.1 to 0.9μg /ml with R 2 value of 0.9967. Solubility studies show that BKC is freely soluble inwater and ethanol,andsparingly soluble in acetone. The genotoxicity study results express that the preservative possesses mutagenic effect. Key wordsBenzalkonium chloride, ...

Current Drug Discovery Technologies, 2022

Background: CCR5 and/or CXCR4 receptors on CD4+ T cell membranes are the active sites for HIV to ... more Background: CCR5 and/or CXCR4 receptors on CD4+ T cell membranes are the active sites for HIV to bind. The different classes of drugs have a unique mechanism of action to cease the virus, but we are concentrating in the first-class i.e. NNRTI that destroys the virus while it binds to the cell surface gp120 protein. The drugs are having several impurities that can be genotoxic and few are reported in the monographs. Objective: This study proposes the affinity of the impurities to the active site through molecular docking to a receptor (PDB ID 4MBS) from the library of analogs available for antiretroviral drugs. As these drugs are taken for the long term, this study will give a prominent idea for testing the impurities and their genotoxicity. Method: We have done molecular docking of 37 impurities and drugs with the GLIDE module of schrodinger software for their binding affinities. In this study, receptor CCR5 and/or CXCR4 is selected containing glycoprotein that mediates virus bindin...

INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE, 2013

Risk is intertwined with every drug product in a market. This article’s intent is to provide grou... more Risk is intertwined with every drug product in a market. This article’s intent is to provide ground rule and praxis of different tools for quality risk management (QRM) in various aspects of pharmaceutical science. QRM comprises of tools and processes which helps in establishing objectives. Hence they are also known as Enablers. Enablers help in risk mitigation of product quality throughout a lifecycle in such a way that benefit outweighs the risk. The key properties of Enablers or QRM, i.e., attempts made, solemnness and records shall be compatible with risk scale. The Enablers accomplishment gives recognized, obvious and steps of Enabler process produced by regeneratable methods which is based on customary comprehension to evaluate feasibility, ability to find out risk prejudice. The QRM or Enabler tools can assist the manufacturing company and regulatory bodies to scrutinize, handle, notify, and inspect the risk.

Journal of Young Pharmacists, 2019

Objective: In the pharmaceutical analytical field, effort to analyzing the degradation or related... more Objective: In the pharmaceutical analytical field, effort to analyzing the degradation or related and impurity substances from the complex matrix in the ultra-trace levels is a really a challengeable task. Impurity is any component of the new drug substance that is not the chemical entity defined as the new drug substance. Gemcitabine hydrochloride is a new anticancer bio molecule. According to Indian Pharmacopoeia there is two impurities present in this drug. The literature review exploded that, there is no specific impurity profiling based analytical method developed to estimate the Cytosine. Methods: RP HPLC is developed to quantify and separate Gemcitabine hydrochloride and Cytosine. The Hibar® C 18 (250 x 4.6 mm i.d., 5μ), Column choices as stationary phase, tri ethyl ether and Acetonitrile in ratio of 95:5 with 4.35 (with Orthophosphoric acid) as mobile phase, the flow rate fixed as 1ml/ min. at 279 nm. Results: A retention time found to be 3.44min and 8.28min for gemcitabine and cytosine respectively. The developed method was validated as per ICH guidelines and the method was proved as selective, specific and linear. The assay and recovery studies were carried out the assay limit was 99.19 and 99.32 for bulk drug and formulations respectively. The Cytosine were present 0.7821 µg/ml and 0.6531 µg/ml in the bulk drug and formulation respectively. Conclusion: It can be concluded that the developed RP-HPLC method was found to be suitable for the appraisal of cytosine impurities in Gemcitabine HCl. The developed RP-HPLC is economic and suitable for the use.

Journal of Applied Pharmaceutical Science, 2018

A sensitive LC-MS/MS method has been developed and validated for the quantitative determination o... more A sensitive LC-MS/MS method has been developed and validated for the quantitative determination of Dexlansoprazole from the commercially available formulations. Omeprazole was used as the internal standard. Isocratic separation was achieved using Zorbax SB C 18 column (4.6 × 100 mm, 3 µm) as a stationary phase and the mobile phase consists of (0.5 mM) Ammonium Acetate adjusted to pH 3.5: acetonitrile (30:70 V/V) with a flow of 0.5 mL/min. Detection was carried out by triple quadrupole mass spectrometry with electrospray ionization in positive mode with proton adducts at m/z 370.05 to 251.95 and 346.00 to 198.05 to monitor Dexlansoprazole and Omeprazole. The linearity of the method was found over a concentration range of 0.5-3000 ng/mL with a regression analysis of 0.9994. The percentage recovery of the present method was found to be 94.33 to 99.97%. The LC-MS/MS method was validated as per ICH guidelines. The developed method can be successfully applied for the estimation of Dexlansoprazole in the commercial formulation and in bulk drug.