采用 "分析质量源于设计 "方法开发和验证反相高效液相色谱 (RP-HPLC) 方法,用于测定大宗样品和生物样品中的异桔梗苷元。

IF 1.6 4区 医学 Q4 BIOCHEMICAL RESEARCH METHODS
Assay and drug development technologies Pub Date : 2024-11-01 Epub Date: 2024-11-25 DOI:10.1089/adt.2024.050
Mohamed Nihal P, Debasish Mohapatra, Alam Mohd Adil Alam Manir, Vancha Harish, Sachin Kumar Singh, Sakshi Upendra Lad, Srinivas Sutrapu, Sumant Saini, Sharfuddin Mohd
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引用次数: 0

摘要

本研究的主要目的是采用质量源于设计的分析方法(AQbD),开发并验证一种简单、稳健、经济高效的等度反相高效液相色谱(RP-HPLC)方法,用于测定散装样品和生物样品中的异桔梗皂苷(ISL)。以流动相比例和流速为自变量,以峰面积、保留时间、尾随因子和理论平板为因变量,使用 Design Expert® 软件对方法进行了中心复合设计优化。设计结果表明,乙腈:0.2% 原磷酸(75:25, v/v)组成的流动相和 0.9 mL/min 的流速是最佳的色谱条件。ISL 的检测波长为 364 nm。根据国际协调会议(ICH)Q2(R1)指南对优化后的方法进行了验证。该方法在线性、检出限、定量限、准确度、精密度、稳健性和系统适用性方面均表现优异。所有验证参数都在 ICH 规定的可接受范围内。此外,还分析了该方法在生物样品中的适用性。总之,研究结果表明,所开发和验证的基于 AQbD 的 RP-HPLC 方法非常适合用于大宗样品和生物样品中 ISL 的估计。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Reverse Phase-High-Performance Liquid Chromatography (RP-HPLC) Method Development and Validation Using Analytical Quality-by-Design Approach for Determination of Isoliquiritigenin in Bulk and Biological Sample.

The primary objective of the present investigation is to develop and validate a simple, robust, and cost-effective isocratic reverse phase-high-performance liquid chromatography (RP-HPLC) method for determining isoliquiritigenin (ISL) in both bulk and biological samples using an analytical quality-by-design (AQbD) approach. The central composite design was employed for method optimization using Design Expert® software, by taking mobile phase ratio and flow rate as independent variables and peak area, retention time, tailing factor, and theoretical plates as dependent variables. The design suggested the use of a mobile phase consisting of acetonitrile:0.2% ortho-phosphoric acid (75:25, v/v) and a flow rate of 0.9 mL/min as optimal chromatographic conditions. The detection of ISL was performed at 364 nm. The optimized method was validated in accordance with International Conference on Harmonization (ICH) Q2(R1) guidelines. The method showed excellent linearity, limit of detection, limit of quantification, accuracy, precision, robustness, and system suitability. All validation parameters fell within the acceptable limits set by ICH. Additionally, the applicability of the method in biological samples were analyzed. In conclusion, the results suggest that the developed and validated AQbD-based RP-HPLC method was well-suited for the estimation of ISL in bulk and biological sample.

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来源期刊
Assay and drug development technologies
Assay and drug development technologies 医学-生化研究方法
CiteScore
3.60
自引率
0.00%
发文量
33
审稿时长
>12 weeks
期刊介绍: ASSAY and Drug Development Technologies provides access to novel techniques and robust tools that enable critical advances in early-stage screening. This research published in the Journal leads to important therapeutics and platforms for drug discovery and development. This reputable peer-reviewed journal features original papers application-oriented technology reviews, topical issues on novel and burgeoning areas of research, and reports in methodology and technology application. ASSAY and Drug Development Technologies coverage includes: -Assay design, target development, and high-throughput technologies- Hit to Lead optimization and medicinal chemistry through preclinical candidate selection- Lab automation, sample management, bioinformatics, data mining, virtual screening, and data analysis- Approaches to assays configured for gene families, inherited, and infectious diseases- Assays and strategies for adapting model organisms to drug discovery- The use of stem cells as models of disease- Translation of phenotypic outputs to target identification- Exploration and mechanistic studies of the technical basis for assay and screening artifacts
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