盐酸二甲双胍和吡格列酮药用剂型hplc同时测定方法的建立及稳定性验证

YMER Digital Pub Date : 2022-08-17 DOI:10.37896/ymer21.08/52

G. Dharmamoorthy

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引用次数: 0

摘要

建立了一种简便、专属性强、准确度高的高效薄层色谱(HPTLC)方法，可对盐酸二甲双胍和吡格列酮的处方进行定量评价。以甲苯:甲醇:三乙胺(6:4:0 1 % v/v/v/v /v)为流动相，实现了盐酸二甲双胍和吡格列酮的高效薄层色谱分离。在230 nm处进行斑点检测，发现盐酸二甲双胍和吡格列酮的Rf值分别为0.25±0.03和0.47±0.04。该方法按照ICH指南进行验证。这些组合的回收率均在96%以上。所开发的方法不受片剂中辅料的干扰。该方法快速简便，不需要任何样品制备，适用于常规的质量控制分析。关键词:HPTLC，方法验证，定量分析

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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND PIOGLITAZONE IN PHARMACEUTICAL DOSAGE FORM

A simple, specific, accurate and precise High Performance Thin Layer Chromatography (HPTLC) method was developed which can separate and quantitatively estimate formulation of Metformin Hydrochloride and Pioglitazone The chromatographic separation for Metformin Hydrochloride and Pioglitazone in HPTLC method separation was achieved with the mobile phase consisting of Toluene: Methanol: Triethylamine (6: 4: 0.1 % v/v/v/v). The detection of spot was carried out at 230 nm and the Rf values Metformin Hydrochloride and Pioglitazone were found to be 0.25±0.03 and 0.47±0.04.. Ths method was validated accordance with ICH guidelines. The recovery these combination were above 96%. The developed method are free from interference due to excipients present in tablets. These method are rapid and simple, do not require any sample preparation and is suitable for routine quality control analysis Keywords: HPTLC ,Method validation, Quantitative analysis

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YMER Digital

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