Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00036
Priyanka M. Sagar, S.D. Mankar, S. B. Dighe
Diabetes mellitus (DM) is a metabolic condition characterized by hyperglycemia, glycosuria, hyperglycemia, a negative nitrogen balance, and occasionally ketonemia. The type 2 sodium-dependent glucose co-transporters (SGLT), which are in charge of roughly 90% of the reabsorption of glucose from the glomerulus, are subject to strong and selective inhibition by ertugliflozin. This review's primary objective is to highlight the development and validation of analytical methods employing chromatographic and spectrophotometric techniques for ertugliflozin and combination products in bulk and pharmaceutical dose forms. RP-HPLC, UV, UPLC, and LC-MS techniques are used to determine the dosage of ertugliflozin when it is combined with metformin and sitagliptin. Spectrometric techniques for ertugliflozin in combination with metformin or sitagliptin contain parameters like solvent, wavelength, linearity, LOD, LOQ, etc., and HPLC methods for ertugliflozin in combination with metformin or sitagliptin include parameters like stationary phase, mobile phase, RT, detection wavelength, LOD, LOQ, etc. Discussions on the separation requirements for ertugliflozin in combination with metformin or sitagliptin are also addressed throughout this review.
{"title":"An Overview on Analytical Method Development and Validation for Ertugliflozin in Bulk and Pharmaceutical Dosage form","authors":"Priyanka M. Sagar, S.D. Mankar, S. B. Dighe","doi":"10.52711/2231-5675.2023.00036","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00036","url":null,"abstract":"Diabetes mellitus (DM) is a metabolic condition characterized by hyperglycemia, glycosuria, hyperglycemia, a negative nitrogen balance, and occasionally ketonemia. The type 2 sodium-dependent glucose co-transporters (SGLT), which are in charge of roughly 90% of the reabsorption of glucose from the glomerulus, are subject to strong and selective inhibition by ertugliflozin. This review's primary objective is to highlight the development and validation of analytical methods employing chromatographic and spectrophotometric techniques for ertugliflozin and combination products in bulk and pharmaceutical dose forms. RP-HPLC, UV, UPLC, and LC-MS techniques are used to determine the dosage of ertugliflozin when it is combined with metformin and sitagliptin. Spectrometric techniques for ertugliflozin in combination with metformin or sitagliptin contain parameters like solvent, wavelength, linearity, LOD, LOQ, etc., and HPLC methods for ertugliflozin in combination with metformin or sitagliptin include parameters like stationary phase, mobile phase, RT, detection wavelength, LOD, LOQ, etc. Discussions on the separation requirements for ertugliflozin in combination with metformin or sitagliptin are also addressed throughout this review.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"59 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00032
Suresh Kumar, Nirma Chavda
Hypertension is a popular disease that is specified by having a lot of quantity of pressure in blood vessels than normal. High blood pressure is a very general disorder, especially past middle age. It is a vital risk issue for cardiovascular mortality. For enhanced activity of hypertension, Rosuvastatin and Fimasartan are newer combination in the market, which is effective in High blood pressure. This combination was developed to enhance medication for Stage II Hypertension. This article gives information about totally different analytical method development like spectrophotometric and chromatographic methods reported for Rosuvastatin and Fimasartan for individual and other drug combinations. All reported methods were found to be simple, accurate, economic, precise and reproducible in nature. This Review delivers on latest development in analytical method development for Rosuvastatin and Fimasartan, and there are no methods reported for this combination as per our knowledge.
{"title":"A Review on Analytical Method Development and Validation for the Simultaneous Estimation of Rosuvastatin and Fimasartan in Bulk and its Pharmaceuticle Dosage Form","authors":"Suresh Kumar, Nirma Chavda","doi":"10.52711/2231-5675.2023.00032","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00032","url":null,"abstract":"Hypertension is a popular disease that is specified by having a lot of quantity of pressure in blood vessels than normal. High blood pressure is a very general disorder, especially past middle age. It is a vital risk issue for cardiovascular mortality. For enhanced activity of hypertension, Rosuvastatin and Fimasartan are newer combination in the market, which is effective in High blood pressure. This combination was developed to enhance medication for Stage II Hypertension. This article gives information about totally different analytical method development like spectrophotometric and chromatographic methods reported for Rosuvastatin and Fimasartan for individual and other drug combinations. All reported methods were found to be simple, accurate, economic, precise and reproducible in nature. This Review delivers on latest development in analytical method development for Rosuvastatin and Fimasartan, and there are no methods reported for this combination as per our knowledge.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00028
Sreenath R, Remi S L
Solubility is a crucial factor during estimation of poorly soluble drugs. Literature survey reveals spectrophotometric estimation of poorly soluble drugs are mostly done by employing organic solvents. The drawbacks of organic solvents include higher cost, toxicity, pollution and error due to volatility. Hydrotropic solubilisation method involves increasing the solubility of a poorly soluble drug in water with the addition of hydrotropic agents. Most of NSAIDs like Meloxicam, Mefenamic acid, Aceclofenacetc are poorly soluble in water. Meloxicam was found to be soluble in mixed hydrotropic solution of 10% sodium benzoate and 10% sodium caprylate with maximum absorbance at 364 nm. The developed method was found to be linear in the range of 2-10 µg/ml with correlation coefficient (R2) of 0.9968. The LOD and LOQ of proposed method was found to be 0.2634 µg/ml and 0.7983 µg/ml respectively. A novel, simple, safe, sensitive and cost-effective spectrophotometric estimation method was developed for estimation of Meloxicam using 10% sodium benzoate and 10% sodium caprylate as hydrotropic agent. This solubilization method can be employed to preclude the use of organic solvents for the estimation of poorly soluble drugs.
{"title":"An Ecofriendly Novel Spectrophotometric Estimation and Validation of Meloxicam in Bulk Drug and their Dosage Form by mixed Hydrotropic Solubilization Method","authors":"Sreenath R, Remi S L","doi":"10.52711/2231-5675.2023.00028","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00028","url":null,"abstract":"Solubility is a crucial factor during estimation of poorly soluble drugs. Literature survey reveals spectrophotometric estimation of poorly soluble drugs are mostly done by employing organic solvents. The drawbacks of organic solvents include higher cost, toxicity, pollution and error due to volatility. Hydrotropic solubilisation method involves increasing the solubility of a poorly soluble drug in water with the addition of hydrotropic agents. Most of NSAIDs like Meloxicam, Mefenamic acid, Aceclofenacetc are poorly soluble in water. Meloxicam was found to be soluble in mixed hydrotropic solution of 10% sodium benzoate and 10% sodium caprylate with maximum absorbance at 364 nm. The developed method was found to be linear in the range of 2-10 µg/ml with correlation coefficient (R2) of 0.9968. The LOD and LOQ of proposed method was found to be 0.2634 µg/ml and 0.7983 µg/ml respectively. A novel, simple, safe, sensitive and cost-effective spectrophotometric estimation method was developed for estimation of Meloxicam using 10% sodium benzoate and 10% sodium caprylate as hydrotropic agent. This solubilization method can be employed to preclude the use of organic solvents for the estimation of poorly soluble drugs.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00031
Prerana Musale, S. D. Mankar
Quality by design is used to designing and developing a formulation and manufacturing process to ensure a predefined quality and this process to enhance capability of process and reduce product variability and defects by increasing product and process design understanding and control. According to guidelines of International conference on Harmonization, Q8, Q9, Q10 are the foundations of Quality by design. Q8 for Pharmaceutical development to design quality of product, Q9 for Quality risk management (QRM) to identify and minimize the risk, Q10 for Pharmaceutical quality system is a management system to give assurity of product quality. Elements of quality by design include Quality Target Product Profile [QTPP] is identify critical Quality Attributes [CQAs] of drug product, product design and identify Critical Material Attributes [CMAs], process design and identify Critical Process Parameters [CPPs], The Control strategy consists of the process and input material control and monitors the design space to identify the final product that ensures the desired quality, process capability and continued improvement. Design of experiment [DoE] is gain to maximum information from a minimum number of experiments and the FDA intimate significance of the quality by granting Process Analytical Technology [PAT] as a framework for brand new pharmaceutical development, manufacturing and the quality assurance. goal of PAT to enhance understanding, control and safety of the manufacturing process and principle of PAT is quality cannot be tested into final product it should be built in or should be by design. Analytical quality by design [AQbD] is also an inherent part of the product development control strategy beside with other parameters such as process parameters, material attributes, equipment operating conditions, in-process controls, and finished product specifications.
{"title":"Quality by Design Approch Based in Analytical Method Validation","authors":"Prerana Musale, S. D. Mankar","doi":"10.52711/2231-5675.2023.00031","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00031","url":null,"abstract":"Quality by design is used to designing and developing a formulation and manufacturing process to ensure a predefined quality and this process to enhance capability of process and reduce product variability and defects by increasing product and process design understanding and control. According to guidelines of International conference on Harmonization, Q8, Q9, Q10 are the foundations of Quality by design. Q8 for Pharmaceutical development to design quality of product, Q9 for Quality risk management (QRM) to identify and minimize the risk, Q10 for Pharmaceutical quality system is a management system to give assurity of product quality. Elements of quality by design include Quality Target Product Profile [QTPP] is identify critical Quality Attributes [CQAs] of drug product, product design and identify Critical Material Attributes [CMAs], process design and identify Critical Process Parameters [CPPs], The Control strategy consists of the process and input material control and monitors the design space to identify the final product that ensures the desired quality, process capability and continued improvement. Design of experiment [DoE] is gain to maximum information from a minimum number of experiments and the FDA intimate significance of the quality by granting Process Analytical Technology [PAT] as a framework for brand new pharmaceutical development, manufacturing and the quality assurance. goal of PAT to enhance understanding, control and safety of the manufacturing process and principle of PAT is quality cannot be tested into final product it should be built in or should be by design. Analytical quality by design [AQbD] is also an inherent part of the product development control strategy beside with other parameters such as process parameters, material attributes, equipment operating conditions, in-process controls, and finished product specifications.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00029
N. Sudarshan Rao, Budda Leena
Olmesartan is an angiotensin II antagonist used in the treatment of hypertension. In present investigation an attempt was made to develop solid oral formulation of Olmesartan. The purpose of this study was to develop the formulation as immediate release tablet of Olmesartan by using excipients by design of experiment. Tablets were prepared by using direct compression method. In HPLC study of Olmesartan the correlation coefficient was found to be 0.993 at 296 nm at flow rate of 0.7 ml/min at injection volume of 5 L Tablets were evaluated for hardness, thickness, dissolution calibration study, drug content and all the in-vitro studies were performed using USP apparatus type II All in-vitro studies were carried out using Phosphate buffer at 37°C ± 0.5°C. The optimized formulation showed in- vitro drug release of 96. 80 % at the end of 60 min. Comparing to other ARB’s drug shows high affinity Angiotensin II type 1 (AT1) receptors has long duration of action. Olmesartan has longest half life of 24 hrs where, T max is 0.5 – 1 hr, and it was so rapidly achieving desired plasma concentrations. Stability studies were carried out according to ICH guidelines. All the results were obtained within given ICH limits.
{"title":"Process Optimization and Evaluation of Immediate Release Tablet containing Benzimidazoles","authors":"N. Sudarshan Rao, Budda Leena","doi":"10.52711/2231-5675.2023.00029","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00029","url":null,"abstract":"Olmesartan is an angiotensin II antagonist used in the treatment of hypertension. In present investigation an attempt was made to develop solid oral formulation of Olmesartan. The purpose of this study was to develop the formulation as immediate release tablet of Olmesartan by using excipients by design of experiment. Tablets were prepared by using direct compression method. In HPLC study of Olmesartan the correlation coefficient was found to be 0.993 at 296 nm at flow rate of 0.7 ml/min at injection volume of 5 L Tablets were evaluated for hardness, thickness, dissolution calibration study, drug content and all the in-vitro studies were performed using USP apparatus type II All in-vitro studies were carried out using Phosphate buffer at 37°C ± 0.5°C. The optimized formulation showed in- vitro drug release of 96. 80 % at the end of 60 min. Comparing to other ARB’s drug shows high affinity Angiotensin II type 1 (AT1) receptors has long duration of action. Olmesartan has longest half life of 24 hrs where, T max is 0.5 – 1 hr, and it was so rapidly achieving desired plasma concentrations. Stability studies were carried out according to ICH guidelines. All the results were obtained within given ICH limits.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"80 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00025
Vaishali N. Sonawane, Chaitali A. Yeola, Vijayraj N. Sonawane, Khemchand R. Surana, Dhananjay M. Patil, Deepak D. Sonawane
Paracetamol is a widely used non-prescription medication and is available in several brands in the market which makes it difficult to select the safe and effective one. Therefore, the study aims to establish the pharmaceutical equivalence of the different brands of paracetamol tablets and to justify the quality of different brands available in the market. The study involves the quantitative analysis of ten different brands of Paracetamol 500 mg tablets, using Ultra Violet Spectrophotometric methods, in which the samples were dissolved in 0.1M sodium hydroxide solution and distilled water and their various absorbances determined at the wavelength (λmax) of 257nm. Quantitative estimation of Paracetamol carried out by UV-Visible spectrophotometric methods, by using standard absorptivity value (assay method given in Indian Pharmacopoeia) and calibration curve method. The percentage content for each sample was calculated byboth methods using appropriate formulae and also determined whether or not they comply with standard specifications as per IP. The percentage content of paracetamol in different brands of paracetamol tablets was compared by IP Method. The results obtained by the IP method and Calibration curve method were also compared.
{"title":"Estimation of Paracetamol in various brands of Paracetamol Tablets and their Comparative Study","authors":"Vaishali N. Sonawane, Chaitali A. Yeola, Vijayraj N. Sonawane, Khemchand R. Surana, Dhananjay M. Patil, Deepak D. Sonawane","doi":"10.52711/2231-5675.2023.00025","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00025","url":null,"abstract":"Paracetamol is a widely used non-prescription medication and is available in several brands in the market which makes it difficult to select the safe and effective one. Therefore, the study aims to establish the pharmaceutical equivalence of the different brands of paracetamol tablets and to justify the quality of different brands available in the market. The study involves the quantitative analysis of ten different brands of Paracetamol 500 mg tablets, using Ultra Violet Spectrophotometric methods, in which the samples were dissolved in 0.1M sodium hydroxide solution and distilled water and their various absorbances determined at the wavelength (λmax) of 257nm. Quantitative estimation of Paracetamol carried out by UV-Visible spectrophotometric methods, by using standard absorptivity value (assay method given in Indian Pharmacopoeia) and calibration curve method. The percentage content for each sample was calculated byboth methods using appropriate formulae and also determined whether or not they comply with standard specifications as per IP. The percentage content of paracetamol in different brands of paracetamol tablets was compared by IP Method. The results obtained by the IP method and Calibration curve method were also compared.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00035
Dinesh B. Marathe, Rohini M. Koli, Kunal S. Mahajan, R. R. Patil, Vinod A. Chaure
As an antidepressant, escitalopram oxalate, a pure S-enantiomer derivative of citalopram, blocks selective serotonin reuptake. By preventing serotonin reuptake and boosting serotonin levels in synaptic clefts, this action exerts an antidepressant effect. The analytical method used to identify Escitalopram oxalate in pharmaceutical formulations, both alone and in combination with other antidepressants, was identified in this review. The simultaneous comparison and discussion of eighteen analytical techniques, including HPLC, HPTLC, stability-indicating strategies, UV spectroscopy, hyphenated techniques and bioanalytical procedures, is best demonstrated by this thorough analysis. Analytical development must be validated in order to produce reliable results for regulatory filings. The invention of drugs resulted in a revolution in human health.
{"title":"Analytical Review on Escitalopram oxalate and their combinations in Bulk and Pharmaceutical Formulation","authors":"Dinesh B. Marathe, Rohini M. Koli, Kunal S. Mahajan, R. R. Patil, Vinod A. Chaure","doi":"10.52711/2231-5675.2023.00035","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00035","url":null,"abstract":"As an antidepressant, escitalopram oxalate, a pure S-enantiomer derivative of citalopram, blocks selective serotonin reuptake. By preventing serotonin reuptake and boosting serotonin levels in synaptic clefts, this action exerts an antidepressant effect. The analytical method used to identify Escitalopram oxalate in pharmaceutical formulations, both alone and in combination with other antidepressants, was identified in this review. The simultaneous comparison and discussion of eighteen analytical techniques, including HPLC, HPTLC, stability-indicating strategies, UV spectroscopy, hyphenated techniques and bioanalytical procedures, is best demonstrated by this thorough analysis. Analytical development must be validated in order to produce reliable results for regulatory filings. The invention of drugs resulted in a revolution in human health.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00034
S. D. Mankar, Tanishka Pawar, Prerana Musale
In the last 4 years, pharmacometrics (PMX) has advanced to the point that it is now a crucial part of drug development. Drug delivery systems and molecules with more complex architecture are being developed as technology advances. Pharmacodynamic modelling is based on the quantitative integration of pharmacokinetics, pharmacological systems, and (patho-) physiological processes in order to comprehend the intensity and time course of drug effects on the body. As a result, the drug absorption and disposition processes after the administration of these drug delivery systems and engineered molecules become exceedingly complex. The research field of drug delivery focuses on the development of new techniques to manipulate drug absorption and disposition to achieve a desirable effect for the PMX model used. An opportunity to combine pharmacokinetic and pharmacodynamic model-based estimations with pharmacoeconomic models emerges given the unpredictability in the dose-concentration-effect relationship of medications. Model-based drug development (MBDD) has been found to address the underlying causes of medication failure, hence enhancing the productivity, effectiveness, and success of late-stage clinical research. The pharmacokinetic (PK) model principles in optimizing the drug dose to suit individual patient needs and achieving maximum therapeutic utility are called clinical pharmacology. Pharmacodynamics (PD) relates response to the concentration of drugs in the body. Disease progression model-based evaluation of disease progression is an important aspect of drug development and pharmacology. The future perspective of pharmacometrics in drug development and clinical practices is challenging.
{"title":"Pharmacometrics: Application in Drug Development and Clinical Practice","authors":"S. D. Mankar, Tanishka Pawar, Prerana Musale","doi":"10.52711/2231-5675.2023.00034","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00034","url":null,"abstract":"In the last 4 years, pharmacometrics (PMX) has advanced to the point that it is now a crucial part of drug development. Drug delivery systems and molecules with more complex architecture are being developed as technology advances. Pharmacodynamic modelling is based on the quantitative integration of pharmacokinetics, pharmacological systems, and (patho-) physiological processes in order to comprehend the intensity and time course of drug effects on the body. As a result, the drug absorption and disposition processes after the administration of these drug delivery systems and engineered molecules become exceedingly complex. The research field of drug delivery focuses on the development of new techniques to manipulate drug absorption and disposition to achieve a desirable effect for the PMX model used. An opportunity to combine pharmacokinetic and pharmacodynamic model-based estimations with pharmacoeconomic models emerges given the unpredictability in the dose-concentration-effect relationship of medications. Model-based drug development (MBDD) has been found to address the underlying causes of medication failure, hence enhancing the productivity, effectiveness, and success of late-stage clinical research. The pharmacokinetic (PK) model principles in optimizing the drug dose to suit individual patient needs and achieving maximum therapeutic utility are called clinical pharmacology. Pharmacodynamics (PD) relates response to the concentration of drugs in the body. Disease progression model-based evaluation of disease progression is an important aspect of drug development and pharmacology. The future perspective of pharmacometrics in drug development and clinical practices is challenging.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00030
Chaitali A. Yeola, Vaishali N. Sonawane, Vijayraj N. Sonawane, Khemchand R. Surana, Dhananjay M. Patil, Deepak D. Sonawane
Analytical method validation is the process of proving or documenting that an analytical method produces data that can be used for what it was made for. The main goal of an analytical procedure is to get results that can be repeated and can be trusted and are good enough for the intended purpose. An effective and simple method was developed and validated for quantitative analysis of Diclofenac sodium by using UV Visible Spectroscopy. The absorption maxima (λmax) were found to be 275nm by using Distilled Water as Solvent. The λmax 275nm was used for the whole study. The linearity range was 8-16 μg/ml with a correlation coefficient (r2) of 0.9969. The method was precise and robust with a %RSD less than 2%. The solution was found to be stable up to 4 hours. The proposed method was accurate and specific as per ICH guidelines (Q2).
{"title":"Development and Validation of Simple UV- Spectrophotometric Method for Estimation of Diclofenac Sodium","authors":"Chaitali A. Yeola, Vaishali N. Sonawane, Vijayraj N. Sonawane, Khemchand R. Surana, Dhananjay M. Patil, Deepak D. Sonawane","doi":"10.52711/2231-5675.2023.00030","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00030","url":null,"abstract":"Analytical method validation is the process of proving or documenting that an analytical method produces data that can be used for what it was made for. The main goal of an analytical procedure is to get results that can be repeated and can be trusted and are good enough for the intended purpose. An effective and simple method was developed and validated for quantitative analysis of Diclofenac sodium by using UV Visible Spectroscopy. The absorption maxima (λmax) were found to be 275nm by using Distilled Water as Solvent. The λmax 275nm was used for the whole study. The linearity range was 8-16 μg/ml with a correlation coefficient (r2) of 0.9969. The method was precise and robust with a %RSD less than 2%. The solution was found to be stable up to 4 hours. The proposed method was accurate and specific as per ICH guidelines (Q2).","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"2011 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-07DOI: 10.52711/2231-5675.2023.00033
Madhavi T. Bhosale, Pravin R. Dighe
The hyphenated techniques are developed by combining two or three different analytical techniques. Mainly chromatographic techniques are combined with spectroscopic techniques. The separated components obtained from chromatographic techniques are then transmitted to spectroscopic detection technique through an interface. The improvements in hyphenated analytical methods in last two decades have significantly broadened their applications in the analysis of biomolecules especially in natural products. In this review article recent advancement in hyphenated techniques such as GC-MS, LC-MS, LC-NMR, MS-MS, LC-NMR-MS have been highlighted. The term ‘Hyphenated’ refers to separation and identification of the compounds. These techniques also show better analysis of sample compounds with better accuracy, precision and specificity. This review mainly focuses on the instrumental aspects of hyphenated techniques along with their interfaces. The interfaces such as JetOrifice separator interface, Electrospray interface, Atmospheric pressure chemical ionization interface have been covered. It has been concluded that these hyphenated techniques have become more advantageous for the analysis of drugs. This technique is useful for quality control, analytical research, impurity profiling and maintenance for human welfare and development.
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