Pub Date : 2023-03-22DOI: 10.52711/2231-5675.2023.00010
Y. Chowdhary, Babita Kumar
Change Control is the process that management uses to identify, document and authorize changes to an IT environment. It minimizes the likelihood of disruptions, unauthorized alterations and errors. The change control procedures should be designed with the size and complexity of the environment in mind. Change control is used to ensure changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. Change control is used in various industries, including in IT, software development, the pharmaceutical industry, the medical device industry, and other engineering/manufacturing industries. For the IT and software industries, change control is a major aspect of the broader discipline of change management. There are two types of changes 1. Disruptive change 2. Dynamic change. is a non-localized future irreversible and change that affects a portion of an industry. This can be caused by changes in market trends causing a shift in the mode of production to fit the customer demands. Dynamic Change is multi-dimensional change that is predictable on a measurable scale. Change control is a CGMP concept that focuses on managing change to prevent unintended consequences. Manufacturing changes (i.e changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval.
{"title":"Importance of Change control in Pharmaceutical Industry: A Review","authors":"Y. Chowdhary, Babita Kumar","doi":"10.52711/2231-5675.2023.00010","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00010","url":null,"abstract":"Change Control is the process that management uses to identify, document and authorize changes to an IT environment. It minimizes the likelihood of disruptions, unauthorized alterations and errors. The change control procedures should be designed with the size and complexity of the environment in mind. Change control is used to ensure changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. Change control is used in various industries, including in IT, software development, the pharmaceutical industry, the medical device industry, and other engineering/manufacturing industries. For the IT and software industries, change control is a major aspect of the broader discipline of change management. There are two types of changes 1. Disruptive change 2. Dynamic change. is a non-localized future irreversible and change that affects a portion of an industry. This can be caused by changes in market trends causing a shift in the mode of production to fit the customer demands. Dynamic Change is multi-dimensional change that is predictable on a measurable scale. Change control is a CGMP concept that focuses on managing change to prevent unintended consequences. Manufacturing changes (i.e changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87828113","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 : 2023-03-22DOI: 10.52711/2231-5675.2023.00005
Karishma P. Fuse, Vinod H. Jadhav
Nitrosamine impurities in pharmaceutical products have increased attention for safety in the direction of the use of various drugs. Nitrosamines are the class of compounds which represents nitroso group attached to an amine (R1N(-R2)-N=0). Nitrosamines are molecules that have a nitroso group connected to an amine (R1N(-R2)-N=0). Controlling cancer-causing contaminants in pharmaceutical products is critical for predicting and avoiding the carcinogenic risk of medicine in people. According to recent findings, nitrosamine impurities have increased the medicinal product's carcinogenic risk. The literature search was accomplished using PubMed, Google scholar, and the Cochrane library to identify relevant scientific articles using various sensitive techniques and analytical instruments for the detection of nitrosamine impurities from the years 1981 to 2022. The search terms included nitrosamine detection techniques, formation of nitrosamine, HPLC technique for nitrosamine detection, GC-MS/MS, GC-MS/MS, GC-MS-Head space, and GC-QTOF technique for nitrosamine detection, LC-MS/MS technique for nitrosamine detection, The literature search included 29 scientific articles from the English lamnguage, including original research and standard guidelines intended to review all the sensitive techniques for detection of nitrosamine impurities in pharmaceutical products. The current review aims to discuss the highly sensitive, cost effective, accurate and precise methods for the detection of various nitrosamine contaminations in the pharmaceutical products.
药品中亚硝胺类杂质的存在日益引起人们的重视，为各种药品的安全使用指明了方向。亚硝胺是一类亚硝基与胺(R1N(-R2)-N=0)相连的化合物。亚硝胺是一种分子，其亚硝基与胺相连(R1N(-R2)-N=0)。控制药品中的致癌污染物对于预测和避免药物对人的致癌风险至关重要。根据最近的发现，亚硝胺杂质增加了药品的致癌风险。利用PubMed、Google scholar和Cochrane图书馆完成文献检索，利用各种灵敏技术和分析仪器对1981年至2022年的亚硝胺杂质进行检测，鉴定相关的科学文章。检索词包括亚硝胺检测技术、亚硝胺的形成、亚硝胺检测的HPLC技术、亚硝胺检测的GC-MS/MS、GC-MS/MS、GC-MS- head space、亚硝胺检测的GC-QTOF技术、亚硝胺检测的LC-MS/MS技术。包括原创性研究和标准指南，旨在审查药品中亚硝胺杂质检测的所有敏感技术。本文旨在探讨药品中各种亚硝胺污染的高灵敏度、高成本效益、高准确度和高精度的检测方法。
{"title":"Insight into Analytical Techniques for the Detection of Nitrosamine Impurities: A Review","authors":"Karishma P. Fuse, Vinod H. Jadhav","doi":"10.52711/2231-5675.2023.00005","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00005","url":null,"abstract":"Nitrosamine impurities in pharmaceutical products have increased attention for safety in the direction of the use of various drugs. Nitrosamines are the class of compounds which represents nitroso group attached to an amine (R1N(-R2)-N=0). Nitrosamines are molecules that have a nitroso group connected to an amine (R1N(-R2)-N=0). Controlling cancer-causing contaminants in pharmaceutical products is critical for predicting and avoiding the carcinogenic risk of medicine in people. According to recent findings, nitrosamine impurities have increased the medicinal product's carcinogenic risk. The literature search was accomplished using PubMed, Google scholar, and the Cochrane library to identify relevant scientific articles using various sensitive techniques and analytical instruments for the detection of nitrosamine impurities from the years 1981 to 2022. The search terms included nitrosamine detection techniques, formation of nitrosamine, HPLC technique for nitrosamine detection, GC-MS/MS, GC-MS/MS, GC-MS-Head space, and GC-QTOF technique for nitrosamine detection, LC-MS/MS technique for nitrosamine detection, The literature search included 29 scientific articles from the English lamnguage, including original research and standard guidelines intended to review all the sensitive techniques for detection of nitrosamine impurities in pharmaceutical products. The current review aims to discuss the highly sensitive, cost effective, accurate and precise methods for the detection of various nitrosamine contaminations in the pharmaceutical products.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"160 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82648372","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}
The estimate of pharmaceutical and biological materials typically uses the key qualitative and quantitative technique known as high performance liquid chromatography (HPLC). It is the most adaptable, secure, dependable, and quick chromatographic method for determining the quality of medicinal ingredients. This article was written with the intention of reviewing several facets of HPLC, including its mechanism, apparatus, types, and applications.
{"title":"A Review on High Performance Liquid Chromatography (HPLC)","authors":"Sahil Kamble, Sahil Agrawal, Sagar Pagade, Rahul Patil, Nilesh Chaugule, Anuja Patil","doi":"10.52711/2231-5675.2023.00011","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00011","url":null,"abstract":"The estimate of pharmaceutical and biological materials typically uses the key qualitative and quantitative technique known as high performance liquid chromatography (HPLC). It is the most adaptable, secure, dependable, and quick chromatographic method for determining the quality of medicinal ingredients. This article was written with the intention of reviewing several facets of HPLC, including its mechanism, apparatus, types, and applications.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"88 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136274741","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 : 2023-03-22DOI: 10.52711/2231-5675.2023.00007
M. M. Eswarudu, G. Ouchitya, N. S. Reddy, M. Deekshitha, P. Babu
Pharmaceutical analysis is necessary at all stages of the drug development process, including formulation development, stability studies, and quality control. It is also used for characterizing the composition of different dosage forms in quantitative and qualitative ways. Comprehensive literature survey forms the foundation stone for the focused analysis of research activity. This review article represents the collection and discussion of various analytical methods available in the literature for the determination of oral anti-diabetic drugs like Empagliflozin (EMPA), Linagliptin (LINA) and Metformin hydrochloride (MET) for the treatment of type II diabetes mellitus, consisting of UV, TLC, HPTLC, and HPLC. The anticipated review provides details about the comparative utilization of various analytical techniques for the determination of EMPA, LINA and MET. This review article can be effectively explored to conduct future analytical investigation for the estimation of selected drugs in pharmaceutical and biological samples.
{"title":"Review on Analytical Methods for Estimation of Antidiabetic Drugs: Empagliflozin, Linagliptin and Metformin Hydrochloride","authors":"M. M. Eswarudu, G. Ouchitya, N. S. Reddy, M. Deekshitha, P. Babu","doi":"10.52711/2231-5675.2023.00007","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00007","url":null,"abstract":"Pharmaceutical analysis is necessary at all stages of the drug development process, including formulation development, stability studies, and quality control. It is also used for characterizing the composition of different dosage forms in quantitative and qualitative ways. Comprehensive literature survey forms the foundation stone for the focused analysis of research activity. This review article represents the collection and discussion of various analytical methods available in the literature for the determination of oral anti-diabetic drugs like Empagliflozin (EMPA), Linagliptin (LINA) and Metformin hydrochloride (MET) for the treatment of type II diabetes mellitus, consisting of UV, TLC, HPTLC, and HPLC. The anticipated review provides details about the comparative utilization of various analytical techniques for the determination of EMPA, LINA and MET. This review article can be effectively explored to conduct future analytical investigation for the estimation of selected drugs in pharmaceutical and biological samples.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"144 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77501104","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 : 2023-03-22DOI: 10.52711/2231-5675.2023.00008
Harshal D. Patil, Chandrabhan B Patil, Vikas V. Patil, Pankaj S. Patil, Amol R. Pawar
Gas Chromatography (GC In gas chromatography, the components of a sample are dissolved in a solvent and vaporized in order to separate the analytes by distributing the sample between two phases: a stationary phase and a mobile phase) is a normally utilized analytic technique as a part of numerous research and industrial research facilities for quality control and in addition identification and quantitation of components in a mixture Mass spectroscopy is an advanced and powerful technique for qualitative and quantitative analysis. . The flame ionization detector presented here is very easy to construct, extremely sensitive, and readily visible for demonstration purposes. Atomic emission detection (AED) is a sensitive as well as a selective detection technique for gas chromatography (GC) and provides element-specific information the paper focused on Instrumentation, Column, Detector, Application, Advantages and Disadvantages in gas chromatography. Gas chromatography is an analytical tool for the separation of compounds in complex mixtures based on the polarity of compounds. Separation is achieved only for compounds that are volatile or that can be made volatile on derivatization of the compound using derivatizing agents.
{"title":"A Brief Review on Gas Chromatography","authors":"Harshal D. Patil, Chandrabhan B Patil, Vikas V. Patil, Pankaj S. Patil, Amol R. Pawar","doi":"10.52711/2231-5675.2023.00008","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00008","url":null,"abstract":"Gas Chromatography (GC In gas chromatography, the components of a sample are dissolved in a solvent and vaporized in order to separate the analytes by distributing the sample between two phases: a stationary phase and a mobile phase) is a normally utilized analytic technique as a part of numerous research and industrial research facilities for quality control and in addition identification and quantitation of components in a mixture Mass spectroscopy is an advanced and powerful technique for qualitative and quantitative analysis. . The flame ionization detector presented here is very easy to construct, extremely sensitive, and readily visible for demonstration purposes. Atomic emission detection (AED) is a sensitive as well as a selective detection technique for gas chromatography (GC) and provides element-specific information the paper focused on Instrumentation, Column, Detector, Application, Advantages and Disadvantages in gas chromatography. Gas chromatography is an analytical tool for the separation of compounds in complex mixtures based on the polarity of compounds. Separation is achieved only for compounds that are volatile or that can be made volatile on derivatization of the compound using derivatizing agents.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"44 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86555194","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 : 2023-03-22DOI: 10.52711/2231-5675.2023.00002
Pragati R. Kamble, Nikita V. Pandagale, Omkar D. Ghatage, Pramod B. Patil, S. Patil
A new accurate, specific, precise, high performance liquid chromatographic (HPLC) method has been developed and validated for the determination of Febuxostat in bulk and in its pharmaceutical dosage forms of tablet. Acetonitrile: Methanol (70:30) was used as the mobile phase at a flow rate of 1.0ml/min using a Symmetry C18 column Finepack SIL C18T-5 (250x4.6mm, 5m). The effluent was spectroscopically monitored at 314nm. The intraday and inter-day precisions showed coefficients of variation ranged from 0.62% to 2.78% at different levels of concentrations. The calibration curve was linear with a correlation coefficient of 0.9947. The averages of the absolute and relative recoveries were found to be 98.67% to 98.96%. The proposed HPLC method was successfully applied to quantify the amount of Febuxostat in bulk and dosage forms in quality control.
建立了一种准确、专属性、精密度、高效液相色谱法测定非布司他原料药及其片剂剂型的方法。以乙腈:甲醇(70:30)为流动相，流速为1.0ml/min，采用Symmetry C18色谱柱Finepack SIL C18T-5 (250x4.6mm, 5m)。流出物在314nm处进行光谱监测。在不同浓度水平下，日、日间精密度的变异系数在0.62% ~ 2.78%之间。校正曲线呈线性，相关系数为0.9947。相对加样回收率为98.67% ~ 98.96%。所建立的高效液相色谱法可用于定量非布司他原料药和剂型的质量控制。
{"title":"Development and Validation of RP-HPLC Method for Determination of Febuxostat in Bulk and Pharmaceutical Dosage Formulations","authors":"Pragati R. Kamble, Nikita V. Pandagale, Omkar D. Ghatage, Pramod B. Patil, S. Patil","doi":"10.52711/2231-5675.2023.00002","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00002","url":null,"abstract":"A new accurate, specific, precise, high performance liquid chromatographic (HPLC) method has been developed and validated for the determination of Febuxostat in bulk and in its pharmaceutical dosage forms of tablet. Acetonitrile: Methanol (70:30) was used as the mobile phase at a flow rate of 1.0ml/min using a Symmetry C18 column Finepack SIL C18T-5 (250x4.6mm, 5m). The effluent was spectroscopically monitored at 314nm. The intraday and inter-day precisions showed coefficients of variation ranged from 0.62% to 2.78% at different levels of concentrations. The calibration curve was linear with a correlation coefficient of 0.9947. The averages of the absolute and relative recoveries were found to be 98.67% to 98.96%. The proposed HPLC method was successfully applied to quantify the amount of Febuxostat in bulk and dosage forms in quality control.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"2117 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91356803","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 : 2022-11-23DOI: 10.52711/2231-5675.2022.00043
Rahul D. Khaire, P. Y. Pawar
High performance liquid chromatography (HPLC) is an important analytical tool in analyzing drug stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants. Forced degradation studies (chemical and physical stress testing) of new chemical entities and drug products are essential to help develop and demonstrate the specificity of such stability-indicating methods. In addition to demonstrating specificity, forced degradation studies can be used to determine the degradation pathways and degradation products of the APIs that could form during storage, and facilitate formulation development, manufacturing, and packaging. ICH guidelines demonstrate certain degradation conditions like light, oxidation, dry heat, acidic, basic, hydrolysis etc. ICH Q1A, QIB and Q2B exemplify the forced degradation studies. This review overviews the approaches and trends that are used in forced degradation studies.
{"title":"A Review on Development of Stability Indicating Analytical Methods for drugs in Bulk and Pharmaceutical Dosage Form","authors":"Rahul D. Khaire, P. Y. Pawar","doi":"10.52711/2231-5675.2022.00043","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00043","url":null,"abstract":"High performance liquid chromatography (HPLC) is an important analytical tool in analyzing drug stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants. Forced degradation studies (chemical and physical stress testing) of new chemical entities and drug products are essential to help develop and demonstrate the specificity of such stability-indicating methods. In addition to demonstrating specificity, forced degradation studies can be used to determine the degradation pathways and degradation products of the APIs that could form during storage, and facilitate formulation development, manufacturing, and packaging. ICH guidelines demonstrate certain degradation conditions like light, oxidation, dry heat, acidic, basic, hydrolysis etc. ICH Q1A, QIB and Q2B exemplify the forced degradation studies. This review overviews the approaches and trends that are used in forced degradation studies.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80055623","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 : 2022-11-23DOI: 10.52711/2231-5675.2022.00045
Narendra B. Patil, K. Patil, Sharangouda J. Patil
Nucleic acid identification, separation, purification, sequencing, diagnosis mapping, etc. are emerging field of bioscience. While designing acceptable method is crucial part of analyser. The repetitive task assigned during method the development and controlling the internal as well as external parameters may design a prominent approach for identification. The interpretation is also directed towards functional complexity of genetic disorders. The high-resolution techniques are minimize the biological barriers in recent developments and focusing on independent structure. The nucleic acid analysis is increasing in the field of bioscience and most preferable application in diagnostic laboratories at commercial scale. Identification of nucleic acid sequence will going to be applied in the analytical aspects like forensic samples, medicines, diseases identification, staging and few more environmental applications. The paper highlights the recent developments of laboratory methods in nucleic acid analysis and their commercial paradigm is necessary in current era of developmental perspectives in diagnosis field.
{"title":"Nucleic Acid Analytical Techniques - Current era of Development Perspectives in Diagnosis Field","authors":"Narendra B. Patil, K. Patil, Sharangouda J. Patil","doi":"10.52711/2231-5675.2022.00045","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00045","url":null,"abstract":"Nucleic acid identification, separation, purification, sequencing, diagnosis mapping, etc. are emerging field of bioscience. While designing acceptable method is crucial part of analyser. The repetitive task assigned during method the development and controlling the internal as well as external parameters may design a prominent approach for identification. The interpretation is also directed towards functional complexity of genetic disorders. The high-resolution techniques are minimize the biological barriers in recent developments and focusing on independent structure. The nucleic acid analysis is increasing in the field of bioscience and most preferable application in diagnostic laboratories at commercial scale. Identification of nucleic acid sequence will going to be applied in the analytical aspects like forensic samples, medicines, diseases identification, staging and few more environmental applications. The paper highlights the recent developments of laboratory methods in nucleic acid analysis and their commercial paradigm is necessary in current era of developmental perspectives in diagnosis field.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82079174","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 : 2022-11-23DOI: 10.52711/2231-5675.2022.00046
Amit J. Vyas, Brijesh H. Patel, Ashok B. Patel, Ajay I. Patel, Nilesh K. Patel
This present work carries a brief review on Q-Absorption ratio method in UV-spectrophotometry. Absorption ratio method is used for the ratio of the absorption at two selected wavelengths one of which is iso-absorptive point and other being the λmax of one of the two components. The aim of this article is to give brief idea about various method developed using Q-Absorption ratio methodon combined dosage forms. It shows selection of wavelength, linearity study and choosing solvent for give combine dosage form. This study also gives brief idea about practical and industrial application of Q-Absorption ratio method.
{"title":"A brief Review on Q-absorption Ratio Method in UV-Spectrophotometry","authors":"Amit J. Vyas, Brijesh H. Patel, Ashok B. Patel, Ajay I. Patel, Nilesh K. Patel","doi":"10.52711/2231-5675.2022.00046","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00046","url":null,"abstract":"This present work carries a brief review on Q-Absorption ratio method in UV-spectrophotometry. Absorption ratio method is used for the ratio of the absorption at two selected wavelengths one of which is iso-absorptive point and other being the λmax of one of the two components. The aim of this article is to give brief idea about various method developed using Q-Absorption ratio methodon combined dosage forms. It shows selection of wavelength, linearity study and choosing solvent for give combine dosage form. This study also gives brief idea about practical and industrial application of Q-Absorption ratio method.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86531941","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 : 2022-11-23DOI: 10.52711/2231-5675.2022.00041
Kalpesh N Patel, Umang H Gajjar, Paresh. U. Patel, Shyam Sunder Pancholi
Haloperidol is a common antipsychotic drug used to treat schizophrenia, and Trihexyphenidyl hydrochloride is an antiparkinsonian medication. The combination formulation is used to treat schizophrenia as well as depression. A simple, accurate, and precise assay as well as a rapid stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Haloperidol (HAL) and Trihexyphenidyl hydrochloride (THP) from their combination drug product have been developed and validated. The proposed method is based on reversed-phase separation of the two drugs using a Zorbax Eclipse XDB C18 column (150 mm x 4.6 mm, 5 um) kept at 30°C. The optimal mobile phase was composed of 0.5 mL triethylamine 0.05 M phosphate buffer having pH 3.75: acetonitrile: (65:35 v/v), a flow rate of 1.2 mL.min-1, and PDA detection at 210 nm. The method was validated in accordance with ICH standards. It was found to be precise and reproducible. Linearity was achieved in the concentration ranges of 6-60 ug mL-1 for HAL and 8-80 ug mL-1 for THP, with correlation coefficients of 0.999 and 1.000, respectively. The mean percent recovery of triplicate samples at each level for both drugs was 99.10-100.7% for Haloperidol and 98.7-100.6% for Trihexyphenidyl hydrochloride. The proposed method can be used to successfully test quality control and stability samples from bulk manufacturing and pharmaceutical dosage forms.
氟哌啶醇是一种常用的抗精神病药物，用于治疗精神分裂症，盐酸三苯基是一种抗帕金森病的药物。这种联合制剂用于治疗精神分裂症和抑郁症。建立了一种简便、准确、精确的测定方法和快速稳定指示反相高效液相色谱(RP-HPLC)同时测定氟哌啶醇(HAL)和盐酸三己苯基(THP)的方法，并进行了验证。该方法采用Zorbax Eclipse XDB C18色谱柱(150 mm x 4.6 mm, 5 um)在30°C下反相分离两种药物。最佳流动相为0.5 mL三乙胺0.05 M磷酸缓冲液，pH为3.75:乙腈:(65:35 v/v)，流速为1.2 mL.min-1, PDA检测波长为210 nm。方法按照ICH标准进行验证。结果表明，该方法精确、可重复性好。HAL在6 ~ 60 ug mL-1和THP在8 ~ 80 ug mL-1浓度范围内呈线性关系，相关系数分别为0.999和1.000。氟哌啶醇和盐酸三己苯酯的平均回收率分别为99.10 ~ 100.7%和98.7 ~ 100.6%。所提出的方法可用于成功地测试来自批量生产和药物剂型的质量控制和稳定性样品。
{"title":"Development and Validation of RP-HPLC Method for Simultaneous Estimation of Haloperidol and Trihexyphenidyl Hydrochloride in Tablet Dosage Form","authors":"Kalpesh N Patel, Umang H Gajjar, Paresh. U. Patel, Shyam Sunder Pancholi","doi":"10.52711/2231-5675.2022.00041","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00041","url":null,"abstract":"Haloperidol is a common antipsychotic drug used to treat schizophrenia, and Trihexyphenidyl hydrochloride is an antiparkinsonian medication. The combination formulation is used to treat schizophrenia as well as depression. A simple, accurate, and precise assay as well as a rapid stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Haloperidol (HAL) and Trihexyphenidyl hydrochloride (THP) from their combination drug product have been developed and validated. The proposed method is based on reversed-phase separation of the two drugs using a Zorbax Eclipse XDB C18 column (150 mm x 4.6 mm, 5 um) kept at 30°C. The optimal mobile phase was composed of 0.5 mL triethylamine 0.05 M phosphate buffer having pH 3.75: acetonitrile: (65:35 v/v), a flow rate of 1.2 mL.min-1, and PDA detection at 210 nm. The method was validated in accordance with ICH standards. It was found to be precise and reproducible. Linearity was achieved in the concentration ranges of 6-60 ug mL-1 for HAL and 8-80 ug mL-1 for THP, with correlation coefficients of 0.999 and 1.000, respectively. The mean percent recovery of triplicate samples at each level for both drugs was 99.10-100.7% for Haloperidol and 98.7-100.6% for Trihexyphenidyl hydrochloride. The proposed method can be used to successfully test quality control and stability samples from bulk manufacturing and pharmaceutical dosage forms.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75749171","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：