Development and Validation of New Methods for Quality Control of the Antiviral Substance FAVIPIRAVIR

IF 0.7 Q4 CHEMISTRY, ANALYTICAL Methods and Objects of Chemical Analysis Pub Date : 2023-01-01 DOI:10.17721/moca.2023.70-80

Yu.V. Scrypynets, G.O. Fedosenko, G.V. Maltsev, I.I. Chebotarska, D.I. Aleksandrova, S.N. Kashutskуy, A.V. Yegorova

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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.

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抗病毒药物FAVIPIRAVIR质量控制新方法的建立与验证

引入药物生产涉及建立药物档案，其中一个重要组成部分是药物开发和质量控制方法的数据。研究了抗病毒物质法匹拉韦的理化性质，并编制了分析文献的基本部分。借助物理、化学和理化分析的综合方法，开发了“鉴定”试验，并证实了favipiravir的结构。建立了适用于物质质量控制的高效液相色谱-紫外检测法和酸碱滴定法测定法匹拉韦中有关物质的方法。建立了所有杂质的相对保留时间和计算其含量的校正因子。在研究浓度范围内，对方法的特异性、准确性、正确性和线性进行了验证。

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Methods and Objects of Chemical Analysis CHEMISTRY, ANALYTICAL-

CiteScore

1.00

自引率

14.30%

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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.