Central Composite Design Expert-Supported RP-HPLC Optimization and Quantitative Evaluation of Efonidipine Hydrochloride Ethanolate & Chlorthalidone in Tablet.

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2024-07-10 DOI:10.1093/chromsci/bmad077
Bhoomi D Patel, Hitesh J Vekaria
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Abstract

Central composite design based RP-HPLC method optimization for the synchronized analysis of Efonidipine Hydrochloride Ethanolate (EFE) and Chlorthalidone (CHL) in tablet. The effective separation was performed using Inertsil ODS C18 column (250 × 4.6 mm, 5 μm), PDA detector with 0.05 M KH2PO4 Buffer (pH 4.5): Acetonitrile (40:60%v/v) mobile phase. Independent variables were investigated include the concentration of KH2PO4 (X1) and flow rate of mobile phase (X2). Based on responses obtained (retention time, resolution and tailing factor), the optimum condition selected was X1 = 40% and X2 = 1 ml/min. Optimized HPLC condition was validated by assessing validation parameters and it meets the acceptance criteria set by ICH. The linear calibration curve was found to be in the quantity range 6.25-18.75 and 20-60 μg/ml Assay of drugs was 100.94 and 100.06% for CHL and EFE. The validated RP-HPLC-PDA method can be used for routine analysis of EFE and CHL in tablet.

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中央配合物设计专家支持的RP-HPLC法优化和定量评价盐酸埃夫尼地平片中乙醇和氯噻酮的含量。
基于中心复合设计的RP-HPLC法优化盐酸乙磺酸埃夫尼地平(EFE)和氯噻酮(CHL)片剂的同步分析。使用Inertsil ODS C18柱(250 × 4.6mm,5μm),PDA检测器,具有0.05M KH2PO4缓冲液(pH 4.5):乙腈(40:60%v/v)流动相。研究的自变量包括KH2PO4的浓度(X1)和流动相的流速(X2)。根据获得的响应(保留时间、分辨率和拖尾因子),选择的最佳条件为X1 = 40%和X2 = 1毫升/分钟。通过评估验证参数对优化的HPLC条件进行了验证,并符合ICH设定的验收标准。线性校准曲线在6.25-18.75和20-60μg/ml范围内。CHL和EFE的药物含量分别为100.94%和100.06%。经验证的RP-HPLC-PDA方法可用于片剂中EFE和CHL的常规分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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