Asian Journal of Pharmaceutical Analysis最新文献_第4页

Importance of Change control in Pharmaceutical Industry: A Review 制药行业变更控制的重要性:综述

Asian Journal of Pharmaceutical Analysis Pub Date : 2023-03-22 DOI: 10.52711/2231-5675.2023.00010

Y. Chowdhary, Babita Kumar

{"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}

引用次数: 0

Insight into Analytical Techniques for the Detection of Nitrosamine Impurities: A Review 亚硝胺类杂质检测分析技术进展综述

Asian Journal of Pharmaceutical Analysis Pub Date : 2023-03-22 DOI: 10.52711/2231-5675.2023.00005

Karishma P. Fuse, Vinod H. Jadhav

{"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}

引用次数: 0

A Review on High Performance Liquid Chromatography (HPLC) 高效液相色谱(HPLC)研究进展

Asian Journal of Pharmaceutical Analysis Pub Date : 2023-03-22 DOI: 10.52711/2231-5675.2023.00011

Sahil Kamble, Sahil Agrawal, Sagar Pagade, Rahul Patil, Nilesh Chaugule, Anuja Patil

引用次数: 0

Review on Analytical Methods for Estimation of Antidiabetic Drugs: Empagliflozin, Linagliptin and Metformin Hydrochloride 降糖药恩格列净、利格列汀、盐酸二甲双胍的分析方法综述

Asian Journal of Pharmaceutical Analysis Pub Date : 2023-03-22 DOI: 10.52711/2231-5675.2023.00007

M. M. Eswarudu, G. Ouchitya, N. S. Reddy, M. Deekshitha, P. Babu

引用次数: 0

A Brief Review on Gas Chromatography 气相色谱技术综述

Asian Journal of Pharmaceutical Analysis Pub Date : 2023-03-22 DOI: 10.52711/2231-5675.2023.00008

Harshal D. Patil, Chandrabhan B Patil, Vikas V. Patil, Pankaj S. Patil, Amol R. Pawar

{"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}

引用次数: 0

Development and Validation of RP-HPLC Method for Determination of Febuxostat in Bulk and Pharmaceutical Dosage Formulations 反相高效液相色谱法测定原料药和制剂中非布司他含量的建立与验证

Asian Journal of Pharmaceutical Analysis Pub Date : 2023-03-22 DOI: 10.52711/2231-5675.2023.00002

Pragati R. Kamble, Nikita V. Pandagale, Omkar D. Ghatage, Pramod B. Patil, S. Patil

引用次数: 0

A Review on Development of Stability Indicating Analytical Methods for drugs in Bulk and Pharmaceutical Dosage Form 原料药和制剂稳定性指示分析方法的发展综述

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00043

Rahul D. Khaire, P. Y. Pawar

引用次数: 0

Nucleic Acid Analytical Techniques - Current era of Development Perspectives in Diagnosis Field 核酸分析技术——诊断领域当前的发展前景

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00045

Narendra B. Patil, K. Patil, Sharangouda J. Patil

{"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}

引用次数: 0

A brief Review on Q-absorption Ratio Method in UV-Spectrophotometry 紫外分光光度法中q -吸收比法的研究进展

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00046

Amit J. Vyas, Brijesh H. Patel, Ashok B. Patel, Ajay I. Patel, Nilesh K. Patel

引用次数: 2

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Haloperidol and Trihexyphenidyl Hydrochloride in Tablet Dosage Form 反相高效液相色谱法同时测定片剂中氟哌啶醇和盐酸三己苯酯的含量

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00041

Kalpesh N Patel, Umang H Gajjar, Paresh. U. Patel, Shyam Sunder Pancholi

{"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}

引用次数: 0