Metformin HCl (MET) is a mostly used antidiabetic drug and several fixed-dose combinations are available in the market with other antidiabetic drugs for the treatment of insulin-independent diabetes. Numerous chromatographic methods have been reported for the estimation of multiple fixed dose combination (FDC) of MET but each FDC needs a separate and dedicated chromatographic method for analysis. No chromatographic method has been reported yet in the literature which promotes synchronous estimation of multiple FDCs of MET to minimize organic solvent consumption, time and cost of analysis. Hence, the multipurpose-high performance thin layer chromatography (HPTLC) method was developed for the synchronous estimation of FDCs of MET by the implementation of an enhanced analytical quality by design approach. Principal component analysis was applied for the identification of critical method risk parameters. Box–Behnken design was applied for response surface analysis. The method operable design ranges was navigated and the control strategy was framed. The developed method was applied for the analysis of multiple FDCs of metformin. The developed method can synchronously analyze multiple FDCs of MET which required several chromatographic methods. Hence, the present method is multipurpose-HPTLC for the synchronous estimation of multiple FDCs of MET which required minimum organic solvent, time and cost of analysis.

中文翻译：

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多用途 HPTLC 方法的主成分分析和基于 DoE 的 AQbD 方法，用于同步估计盐酸二甲双胍、瑞格列奈、格列本脲和盐酸吡格列酮的多个 FDC

盐酸二甲双胍 (MET) 是一种最常用的抗糖尿病药物，市场上有几种固定剂量组合可与其他抗糖尿病药物一起用于治疗胰岛素依赖型糖尿病。已经报道了许多色谱方法来估计 MET 的多个固定剂量组合 (FDC)，但每个 FDC 都需要单独和专用的色谱方法进行分析。文献中尚未报道促进同步估计 MET 的多个 FDC 以最小化有机溶剂消耗、时间和分析成本的色谱方法。因此，开发了多用途高性能薄层色谱 (HPTLC) 方法，用于通过设计方法提高分析质量来同步估计 MET 的 FDC。主成分分析用于识别关键方法风险参数。Box-Behnken 设计用于响应面分析。导航了方法可操作的设计范围，并制定了控制策略。所开发的方法用于分析二甲双胍的多种 FDC。所开发的方法可以同时分析需要几种色谱方法的 MET 的多个 FDC。因此，本方法是多用途 HPTLC，用于同步估计 MET 的多个 FDC，需要最少的有机溶剂、时间和分析成本。所开发的方法用于分析二甲双胍的多种 FDC。所开发的方法可以同时分析需要几种色谱方法的 MET 的多个 FDC。因此，本方法是多用途 HPTLC，用于同步估计 MET 的多个 FDC，需要最少的有机溶剂、时间和分析成本。所开发的方法用于分析二甲双胍的多种 FDC。所开发的方法可以同时分析需要几种色谱方法的 MET 的多个 FDC。因此，本方法是多用途 HPTLC，用于同步估计 MET 的多个 FDC，需要最少的有机溶剂、时间和分析成本。