{"title":"抗病毒药物FAVIPIRAVIR质量控制新方法的建立与验证","authors":"Yu.V. Scrypynets, G.O. Fedosenko, G.V. Maltsev, I.I. Chebotarska, D.I. Aleksandrova, S.N. Kashutskуy, A.V. Yegorova","doi":"10.17721/moca.2023.70-80","DOIUrl":null,"url":null,"abstract":"The introduction into the production of medicinal substances involves the creation of a pharmaceutical dossier, an important component of which is data on pharmaceutical development and quality control methods. The physico-chemical properties of the antiviral substance of favipiravir were investigated, and some basic sections of the analytical documentation were developed. With the help of a complex of physical, chemical, and physico-chemical methods of analysis, the \"Identification\" test was developed, and the structure of favipiravir was proven. Methods for the determination of related substances by the HPLC with UV detection and the assay of favipiravir by the acid-base titration method, suitable for substance quality control, have been developed. Relative retention times and correction factors for calculating their content are established for all impurities. The methods were validated on the parameters of specificity, accuracy, correctness, and linearity in the studied range of concentrations.","PeriodicalId":18626,"journal":{"name":"Methods and Objects of Chemical Analysis","volume":null,"pages":null},"PeriodicalIF":0.7000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development and Validation of New Methods for Quality Control of the Antiviral Substance FAVIPIRAVIR\",\"authors\":\"Yu.V. Scrypynets, G.O. Fedosenko, G.V. Maltsev, I.I. Chebotarska, D.I. Aleksandrova, S.N. Kashutskуy, A.V. Yegorova\",\"doi\":\"10.17721/moca.2023.70-80\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The introduction into the production of medicinal substances involves the creation of a pharmaceutical dossier, an important component of which is data on pharmaceutical development and quality control methods. The physico-chemical properties of the antiviral substance of favipiravir were investigated, and some basic sections of the analytical documentation were developed. With the help of a complex of physical, chemical, and physico-chemical methods of analysis, the \\\"Identification\\\" test was developed, and the structure of favipiravir was proven. Methods for the determination of related substances by the HPLC with UV detection and the assay of favipiravir by the acid-base titration method, suitable for substance quality control, have been developed. Relative retention times and correction factors for calculating their content are established for all impurities. The methods were validated on the parameters of specificity, accuracy, correctness, and linearity in the studied range of concentrations.\",\"PeriodicalId\":18626,\"journal\":{\"name\":\"Methods and Objects of Chemical Analysis\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.7000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Methods and Objects of Chemical Analysis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17721/moca.2023.70-80\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Methods and Objects of Chemical Analysis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17721/moca.2023.70-80","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
Development and Validation of New Methods for Quality Control of the Antiviral Substance FAVIPIRAVIR
The introduction into the production of medicinal substances involves the creation of a pharmaceutical dossier, an important component of which is data on pharmaceutical development and quality control methods. The physico-chemical properties of the antiviral substance of favipiravir were investigated, and some basic sections of the analytical documentation were developed. With the help of a complex of physical, chemical, and physico-chemical methods of analysis, the "Identification" test was developed, and the structure of favipiravir was proven. Methods for the determination of related substances by the HPLC with UV detection and the assay of favipiravir by the acid-base titration method, suitable for substance quality control, have been developed. Relative retention times and correction factors for calculating their content are established for all impurities. The methods were validated on the parameters of specificity, accuracy, correctness, and linearity in the studied range of concentrations.
期刊介绍:
The journal "Methods and objects of chemical analysis" is peer-review journal and publishes original articles of theoretical and experimental analysis on topical issues and bio-analytical chemistry, chemical and pharmaceutical analysis, as well as chemical metrology. Submitted works shall cover the results of completed studies and shall make scientific contributions to the relevant area of expertise. The journal publishes review articles, research articles and articles related to latest developments of analytical instrumentations.