主成分分析和doe驱动的绿色分析化学概念在液相色谱法评价复方降压药中的应用。

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL Journal of AOAC International Pub Date : 2023-07-17 DOI:10.1093/jaoacint/qsad016
Pintu Prajapati, Hetal Jariwala, Bhumika Prajapati, Minal Salunkhe, Veera Shakar Pulusu, Shailesh Shah
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引用次数: 1

摘要

背景:琥珀酸美托洛尔(MTS)、西尼地平(CDN)和替米沙坦(TST)的固定剂量联合(FDC)用于治疗高血压。文献中已经报道了许多反相(RP)-HPLC方法用于MTS, CDN和TST的色谱分析。根据绿色分析化学(GAC)的概念,在色谱方法开发过程中,为了分析人员的安全和环境的保护,应避免或尽量减少有毒有机溶剂的使用。采用乙腈(ACN)或甲醇作为流动相的有机组分和样品制备的稀释剂,建立了RP-HPLC方法。根据国际统一理事会(ICH) Q3C (R6)指南和辉瑞药物化学溶剂选择(PMCSS)指南,这些有机溶剂被认为是有毒溶剂。目的:建立一种环境友好、经济高效的反相高效液相色谱-光电二极管阵列(PDA)分析MTS、CDN和TST的方法,使用毒性较小的有机溶剂来支持GAC的概念。方法:为避免有机溶剂的浪费,采用化学计量学和实验设计(DoE)进行方法开发。将主成分分析(PCA)作为一种化学计量学工具,用于识别关键方法风险变量(mrv)和方法性能属性(mpa)。利用基于doi的响应面模型进一步研究了确定的关键mrv和MPAs,以优化方法。结果:以Shim-pack ODS色谱柱为固定相,乙醇为有机改性剂为流动相,对MTS、CDN和TST进行了色谱分析。将开发的方法应用于fdc的测定,结果发现符合标签声明。采用国家环境方法指数(NEMI)和分析绿色度(AGREE)方法对已报道和现有RP-HPLC方法的绿色度进行评价。结论:与已发表的分析方法相比,开发的方法是绿色的,稳健的,经济的。重点:建立并验证了使用安全有机溶剂同时测定MTS、CDN和TST的RP-HPLC方法。运用PCA和DoE在方法开发中实施设计质量分析(AQbD)方法。MTS、CDN和TST中fdc含量测定方法的应用。
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Application of Principal Component Analysis and DoE-Driven Green Analytical Chemistry Concept to Liquid Chromatographic Method for Estimation of Co-formulated Anti-Hypertensive Drugs.

Background: The fixed-dose combination (FDC) of metoprolol succinate (MTS), cilnidipine (CDN), and telmisartan (TST) is used for the management of hypertension. Numerous reversed phase (RP)-HPLC methods have been reported in the literature for chromatographic analysis of MTS, CDN, and TST. According to the concept of green analytical chemistry (GAC), toxic organic solvents should be avoided or minimized during chromatographic method development for the safety of analysts and the protection of the environment. The reported RP-HPLC methods have been developed using acetonitrile (ACN) or methanol as an organic component of the mobile phase and diluent for sample preparation. These organic solvents are considered toxic solvents as per the International Council for Harmonization (ICH) Q3C (R6) guideline and Pfizer medicinal chemistry solvent selection (PMCSS) guide.

Objective: We aimed to develop an environment-friendly and economical RP-HPLC-photo-diode array (PDA) method for the analysis of MTS, CDN, and TST using less toxic organic solvents to support the concept of GAC.

Methods: The method development was carried out by the implementation of chemometrics and design of experiments (DoE) to avoid wastage of organic solvent. Principal component analysis (PCA) was applied as a chemometric tool for the identification of critical method risk variables (MRVs) and method performance attributes (MPAs). The identified critical MRVs and MPAs were further studied by DoE-based response surface modelling for optimization of the method.

Results: The chromatographic analysis of MTS, CDN, and TST was carried out using a Shim-pack ODS column as a stationary phase and ethanol as an organic modifier in the mobile phase. The developed method was applied to the assay of FDCs and results were found to be in compliance with the label claim. The greenness profiles of reported and present RP-HPLC methods were evaluated by national environmental method index (NEMI) and analytical greenness (AGREE) methods.

Conclusion: The developed method was found to be green, robust, and economical as compared to published methods for the analysis.

Highlights: Development and validation of an RP-HPLC method for simultaneous estimation of MTS, CDN, and TST using safe organic solvents. Implementation of a analytical quality by design (AQbD) approach in method development using PCA and DoE. Application of the method for assay of FDCs of MTS, CDN, and TST.

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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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