Non-Hodgkin's lymphoma (NHL) is recognized as the most common form of lymphoma. Among the var... more Non-Hodgkin's lymphoma (NHL) is recognized as the most common form of lymphoma. Among the various subtypes of NHL, diffuse large B-cell lymphoma (DLBCL) stands out as the predominant type, constituting approximately 30 percent of all lymphomas. DLBCL has an annual incidence rate of 2.9 per 100,000 in men and 1.5 per 100,000 in women in India. It is a rapidly growing and aggressive form of NHL. A 40-year-old male patient presented with a chief complaint of abdominal pain and discomfort persisting for 4-5 months. The patient had previously been diagnosed with AIDS (Acquired immune deficiency syndrome - a retroviral disease) and non-Hodgkin's lymphoma Diffuse Large B-Cell Lymphoma (DLBCL) on 29-04-14. Ileal resection had already been performed on 20-01-2014, and the patient received the initial cycle of CHOP (cyclophosphamide, doxorubicin [Adriamycin], vincristine [Oncovin], prednisolone) chemotherapy on 02-04-14. The MIB index was measured at 70%. The report on 22-04-14 indica...
INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE
Background and Objectives: Econazole nitrate (ECN) loaded nanoparticles with topical administrati... more Background and Objectives: Econazole nitrate (ECN) loaded nanoparticles with topical administration were the focus of the current study, which aimed to improve the topical efficacy of the medicine in treating fungal infections while also mitigating the drug’s gastrointestinal (GI) side effects. Further colloidal carrier methodology was employed as a method for the topical administration of medications with precision. Method: The emulsification-diffusion (E-D) method is an alternate approach for preparing nanogels that avoids the toxicitysolvent issues associated with the emulsification-evaporation technique. Its ease of use, enhanced stability, and adaptability have all been verified by a variety of research groups. ECN loaded with dichloromethane in stabilizer solution, formulated by high-speed homogenization at elevated pressure. The addition of aqueous phase with repeated homogenization cycles causes drug diffusion into nanogels. Further addition of mannitol as cryoprotectant and...
International Journal of Experimental Research and Review
High performance thin layer chromatography (HPTLC) and Ultra-High-Performance Liquid Chromatograp... more High performance thin layer chromatography (HPTLC) and Ultra-High-Performance Liquid Chromatography (UHPLC) techniques were developed and validated to quantify Withanolide in extract and formulation. On Al-backed silica gel 60 F254 TLC plates (10 cm × 10 cm, layer thickness 0.2 mm), which had been prewashed with methanol, HPTLC separation was carried out. Dichloromethane: Methanol: Toluene: Acetone in various ratios produced good separation in mobile phase (5:1:1:0.5 v/v). Camag TLC scanner densitometric scanning at 365 nm determined and quantified. This approach produced compact Withanolide spots at Rf 0.48. ICH guidelines verified HPTLC's precision, reproducibility, and accuracy. Withanolide linearity was 500-3000 ng/spot with R2= 0.9994. LOD & LOQ were found to be 9.48 & 28.73 ng respectively. For UHPLC, Cosmosil C18 was used with acetonitrile: water (0.2 % OPA) (70:30, v/v) mobile phase. Flow rate was 1.5 mL/min. Under optimal chromatographic conditions, Withanolide was reta...
International Journal of Experimental Research and Review
Background: Achieving a predictable degree of quality with intended and planned specifications is... more Background: Achieving a predictable degree of quality with intended and planned specifications is known as "quality by design." QbD (Quality-by-Design) is an alternative to conventional method development that places more attention on identifying and mitigating potential risks. Component of the Quality-by-Design methodology involves conducting a series of experiments to learn how various factors, including the dependant variables, affect the answers of interest. Here, we use a QbD (Quality-by-Design) loom to detail the creation and verification of a stability-indicating high-performance liquid chromatography (HPLC) method for Fostemsavir in both bulk and finished-goods forms. Results: In this work, we present a workable experimental design for optimising the RP-HPLC separation technique by identifying the optimum mobile phase concentration and flow rate. Below are the ideal chromatographic conditions as calculated by Design Expert version 13.0: Mobile phase: 80 parts aceto...
Background: Antiviral drugs gained more importance due to SARS-COV-2 infection and many drugs are... more Background: Antiviral drugs gained more importance due to SARS-COV-2 infection and many drugs are under investigation to end the pandemic. Molnupiravir is an investigational medicinal product being developed by Merck Sharp and Dohme in collaboration with Ridgeback for the treatment of COVID-19. Objective: A new, simple, and economical UV-spectrometric method was developed and validated for the estimation of Molnupiravir in a bulk and pharmaceutical dosage form. Methods: The maximum wavelength was found to be 236 nm. The developed method was validated according to ICH guidelines and found to be linear within the range of 10-50µg/ml with a correlation coefficient (R2) 0.9989. Results: The %RSD for precision, accuracy, LOD, LOQ, Ruggedness, and Robustness were within the range of acceptable limits as per ICH Q2 (R1). The accuracy of the method was determined at three concentration levels and found to be 99.87%, 99.53%, and 99.84%. Conclusion: All parameters obtained are within acceptab...
According to ICH Q3A(R), the impurity in a new drug substance is “any component of a new drug sub... more According to ICH Q3A(R), the impurity in a new drug substance is “any component of a new drug substance that is not the chemical entity defined as a new drug substance”. As Per ICH Q3B(R), the impurity in a new drug product is “any component of the drug product that is not the drug substance and excipients in the drug product. “The forced degradation studies are used to facilitate the development of analytical methodology, to achieve a better understanding of the drug substance and the drug product stability, and to determine degradation pathways and the degradation products. This study will help to get the most stable formulation. The bioanalytical method development and validation is an essential part in the drug discovery and development. There is need to develop and validate bioanalytical methods, as sponsors have to submit clinical pharmacology, bioavailability, bioequivalence, pharmacokinetic evaluation along with non-human pharmacology and toxicology studies and preclinical s...
A simple, fast, precise method has been developed for estimation of nitazoxanide in tablet formul... more A simple, fast, precise method has been developed for estimation of nitazoxanide in tablet formulation. The sampling wavelengths selected for the drug was 346 nm. Standard stock solutions were prepared in dimethylformamide and the working solutions were prepared in phosphate buffer 7.4 PH. The linearity for the drug at the selected wavelengths lies between 5–25μg/ml for nitazoxanide. The recovery study was performed by using two different brands Nitacure and Nizonide of Nitazoxanide. The percentage Relative standard deviations for recovery study were well within the range.
Analytical Chemistry - Advancement, Perspectives and Applications
According to the International Conference for Harmonization (ICH), the validation and verificatio... more According to the International Conference for Harmonization (ICH), the validation and verification data must be included in the Electronic Common Technical Document. The validated analytical procedure gets automatically Food and drug approved (FDA) if it is part of New drug application (NDA), Abbreviated new drug application (ANDA) or Biologic license application (BLA). The analytical, bioanalytical and stability-indicating methods are essential part of all above said regulatory submissions. There are certain ways to generate these analytical methods like U.S. pharmacopeia/National Formulary which are Food and drug approved. The validated analytical method can also be submitted by any researcher or agency which can gets the food and drug approval. It is necessary that the methods which are Food and drug approved can only be applied to the various drugs and drugs products. In the current chapter, the meaning and requirements of analytical methods, procedures, acceptance criteria and ...
For various types of drug approval processes like INDs, NDAs, ANDAs, veterinary drug approval, th... more For various types of drug approval processes like INDs, NDAs, ANDAs, veterinary drug approval, the data related to bioanalytical method development and validation is needed to sponsors. Various agencies namely US FDA, American association of pharmaceutical scientists (AAPS), Health protection Branch (HPB), Association of analytical chemists (AOAC), Center for Veterinary Medicine (CVM), U.S. Department of Health and Human Services Food and drug Administration, Center for Drug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug administration(CFDA), European Bioanalytical Forum (EBF), Global CRO council (GCC), ANVISA (Brazil), Japan Bioanalytical Forum (JBF) had done collective efforts at different timings to regulate and harmonize bioanalytical method development and validation. Regulatory guidance documents are available as a result of the involvement of various official agencies. Bioanalytical method development and validation can be performed with v...
Non-Hodgkin's lymphoma (NHL) is recognized as the most common form of lymphoma. Among the var... more Non-Hodgkin's lymphoma (NHL) is recognized as the most common form of lymphoma. Among the various subtypes of NHL, diffuse large B-cell lymphoma (DLBCL) stands out as the predominant type, constituting approximately 30 percent of all lymphomas. DLBCL has an annual incidence rate of 2.9 per 100,000 in men and 1.5 per 100,000 in women in India. It is a rapidly growing and aggressive form of NHL. A 40-year-old male patient presented with a chief complaint of abdominal pain and discomfort persisting for 4-5 months. The patient had previously been diagnosed with AIDS (Acquired immune deficiency syndrome - a retroviral disease) and non-Hodgkin's lymphoma Diffuse Large B-Cell Lymphoma (DLBCL) on 29-04-14. Ileal resection had already been performed on 20-01-2014, and the patient received the initial cycle of CHOP (cyclophosphamide, doxorubicin [Adriamycin], vincristine [Oncovin], prednisolone) chemotherapy on 02-04-14. The MIB index was measured at 70%. The report on 22-04-14 indica...
INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE
Background and Objectives: Econazole nitrate (ECN) loaded nanoparticles with topical administrati... more Background and Objectives: Econazole nitrate (ECN) loaded nanoparticles with topical administration were the focus of the current study, which aimed to improve the topical efficacy of the medicine in treating fungal infections while also mitigating the drug’s gastrointestinal (GI) side effects. Further colloidal carrier methodology was employed as a method for the topical administration of medications with precision. Method: The emulsification-diffusion (E-D) method is an alternate approach for preparing nanogels that avoids the toxicitysolvent issues associated with the emulsification-evaporation technique. Its ease of use, enhanced stability, and adaptability have all been verified by a variety of research groups. ECN loaded with dichloromethane in stabilizer solution, formulated by high-speed homogenization at elevated pressure. The addition of aqueous phase with repeated homogenization cycles causes drug diffusion into nanogels. Further addition of mannitol as cryoprotectant and...
International Journal of Experimental Research and Review
High performance thin layer chromatography (HPTLC) and Ultra-High-Performance Liquid Chromatograp... more High performance thin layer chromatography (HPTLC) and Ultra-High-Performance Liquid Chromatography (UHPLC) techniques were developed and validated to quantify Withanolide in extract and formulation. On Al-backed silica gel 60 F254 TLC plates (10 cm × 10 cm, layer thickness 0.2 mm), which had been prewashed with methanol, HPTLC separation was carried out. Dichloromethane: Methanol: Toluene: Acetone in various ratios produced good separation in mobile phase (5:1:1:0.5 v/v). Camag TLC scanner densitometric scanning at 365 nm determined and quantified. This approach produced compact Withanolide spots at Rf 0.48. ICH guidelines verified HPTLC's precision, reproducibility, and accuracy. Withanolide linearity was 500-3000 ng/spot with R2= 0.9994. LOD & LOQ were found to be 9.48 & 28.73 ng respectively. For UHPLC, Cosmosil C18 was used with acetonitrile: water (0.2 % OPA) (70:30, v/v) mobile phase. Flow rate was 1.5 mL/min. Under optimal chromatographic conditions, Withanolide was reta...
International Journal of Experimental Research and Review
Background: Achieving a predictable degree of quality with intended and planned specifications is... more Background: Achieving a predictable degree of quality with intended and planned specifications is known as "quality by design." QbD (Quality-by-Design) is an alternative to conventional method development that places more attention on identifying and mitigating potential risks. Component of the Quality-by-Design methodology involves conducting a series of experiments to learn how various factors, including the dependant variables, affect the answers of interest. Here, we use a QbD (Quality-by-Design) loom to detail the creation and verification of a stability-indicating high-performance liquid chromatography (HPLC) method for Fostemsavir in both bulk and finished-goods forms. Results: In this work, we present a workable experimental design for optimising the RP-HPLC separation technique by identifying the optimum mobile phase concentration and flow rate. Below are the ideal chromatographic conditions as calculated by Design Expert version 13.0: Mobile phase: 80 parts aceto...
Background: Antiviral drugs gained more importance due to SARS-COV-2 infection and many drugs are... more Background: Antiviral drugs gained more importance due to SARS-COV-2 infection and many drugs are under investigation to end the pandemic. Molnupiravir is an investigational medicinal product being developed by Merck Sharp and Dohme in collaboration with Ridgeback for the treatment of COVID-19. Objective: A new, simple, and economical UV-spectrometric method was developed and validated for the estimation of Molnupiravir in a bulk and pharmaceutical dosage form. Methods: The maximum wavelength was found to be 236 nm. The developed method was validated according to ICH guidelines and found to be linear within the range of 10-50µg/ml with a correlation coefficient (R2) 0.9989. Results: The %RSD for precision, accuracy, LOD, LOQ, Ruggedness, and Robustness were within the range of acceptable limits as per ICH Q2 (R1). The accuracy of the method was determined at three concentration levels and found to be 99.87%, 99.53%, and 99.84%. Conclusion: All parameters obtained are within acceptab...
According to ICH Q3A(R), the impurity in a new drug substance is “any component of a new drug sub... more According to ICH Q3A(R), the impurity in a new drug substance is “any component of a new drug substance that is not the chemical entity defined as a new drug substance”. As Per ICH Q3B(R), the impurity in a new drug product is “any component of the drug product that is not the drug substance and excipients in the drug product. “The forced degradation studies are used to facilitate the development of analytical methodology, to achieve a better understanding of the drug substance and the drug product stability, and to determine degradation pathways and the degradation products. This study will help to get the most stable formulation. The bioanalytical method development and validation is an essential part in the drug discovery and development. There is need to develop and validate bioanalytical methods, as sponsors have to submit clinical pharmacology, bioavailability, bioequivalence, pharmacokinetic evaluation along with non-human pharmacology and toxicology studies and preclinical s...
A simple, fast, precise method has been developed for estimation of nitazoxanide in tablet formul... more A simple, fast, precise method has been developed for estimation of nitazoxanide in tablet formulation. The sampling wavelengths selected for the drug was 346 nm. Standard stock solutions were prepared in dimethylformamide and the working solutions were prepared in phosphate buffer 7.4 PH. The linearity for the drug at the selected wavelengths lies between 5–25μg/ml for nitazoxanide. The recovery study was performed by using two different brands Nitacure and Nizonide of Nitazoxanide. The percentage Relative standard deviations for recovery study were well within the range.
Analytical Chemistry - Advancement, Perspectives and Applications
According to the International Conference for Harmonization (ICH), the validation and verificatio... more According to the International Conference for Harmonization (ICH), the validation and verification data must be included in the Electronic Common Technical Document. The validated analytical procedure gets automatically Food and drug approved (FDA) if it is part of New drug application (NDA), Abbreviated new drug application (ANDA) or Biologic license application (BLA). The analytical, bioanalytical and stability-indicating methods are essential part of all above said regulatory submissions. There are certain ways to generate these analytical methods like U.S. pharmacopeia/National Formulary which are Food and drug approved. The validated analytical method can also be submitted by any researcher or agency which can gets the food and drug approval. It is necessary that the methods which are Food and drug approved can only be applied to the various drugs and drugs products. In the current chapter, the meaning and requirements of analytical methods, procedures, acceptance criteria and ...
For various types of drug approval processes like INDs, NDAs, ANDAs, veterinary drug approval, th... more For various types of drug approval processes like INDs, NDAs, ANDAs, veterinary drug approval, the data related to bioanalytical method development and validation is needed to sponsors. Various agencies namely US FDA, American association of pharmaceutical scientists (AAPS), Health protection Branch (HPB), Association of analytical chemists (AOAC), Center for Veterinary Medicine (CVM), U.S. Department of Health and Human Services Food and drug Administration, Center for Drug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug administration(CFDA), European Bioanalytical Forum (EBF), Global CRO council (GCC), ANVISA (Brazil), Japan Bioanalytical Forum (JBF) had done collective efforts at different timings to regulate and harmonize bioanalytical method development and validation. Regulatory guidance documents are available as a result of the involvement of various official agencies. Bioanalytical method development and validation can be performed with v...
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