Stability-indicating HPLC for remogliflozin, vildagliptin, and metformin: Method development, validation, and greenness.

IF 1 Q4 PHARMACOLOGY & PHARMACY

Annales pharmaceutiques francaises Pub Date : 2024-06-28 DOI:10.1016/j.pharma.2024.06.006

Himani Acharya, Rajendra Kotadiya

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引用次数: 0

Abstract

Objective: The present work represents a reverse-phase high-performance liquid chromatography method in addition to stability studies for sequential estimation of remogliflozin etabonate, vildagliptin, and metformin HCl in tablet formulation.

Method: The mentioned method utilizes a Phenomenex Luna C18 column (250×4.6mm, 5μm). It consists of a column oven's temperature of 35°C. Mobile phase includes a mixture of 50% phosphate buffer (pH - 6.8) and 50% acetonitrile along with a flow rate of 0.8mL/min and 20minutes of run time. The injection volume was 20μL; 217nm is a detection wavelength, and a PDA detector is used for detection.

Results: The suggested technique was proven and validated per the ICH Q2 (R1) guideline. The combination was put under stress conditions that included acid, base, thermal, photolytic, and oxidative degradation. The combination was considerably degraded under oxidative, acidic, and basic circumstances for deterioration, and the degradation results were accurately identified from the observed peaks, demonstrating the method's effectiveness in detecting stability.

Conclusion: The technique was quick, precise, sensitive, and accurate; as a result, it may be used in quality control laboratories and the pharmaceutical industry for routine quality monitoring of tablets containing all three medications.

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雷莫格列嗪、维达列汀和二甲双胍的稳定性指示高效液相色谱：方法开发、验证与绿色环保

目的本研究采用反相高效液相色谱法对片剂中依他羧酸雷莫格列汀、维达列汀和盐酸二甲双胍的含量进行了测定和稳定性研究：上述方法采用 Phenomenex Luna C18 色谱柱（250 × 4.6 mm，5 μm）。流动相为 50%磷酸盐缓冲液（pH - 6.8）和 50%乙腈的混合物，流速为 0.8 mL/min，运行时间为 20 分钟。进样量为 20 μL。检测波长为 217 nm，使用 PDA 检测器进行检测：结果：根据 ICH Q2(R1)指南，所建议的技术得到了证实和验证。将组合物置于压力条件下，包括酸、碱、热、光解和氧化降解。在氧化、酸性和碱性条件下，组合药剂发生了明显的降解变质，降解结果可从观察到的峰值中准确识别，证明了该方法在检测稳定性方面的有效性：结论：该技术快速、精确、灵敏、准确，因此可用于质量控制实验室和制药行业对含有这三种药物的片剂进行常规质量监测。

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

Annales pharmaceutiques francaises PHARMACOLOGY & PHARMACY-

CiteScore

1.70

自引率

7.70%

发文量

期刊介绍： This journal proposes a scientific information validated and indexed to be informed about the last research works in all the domains interesting the pharmacy. The original works, general reviews, the focusing, the brief notes, subjected by the best academics and the professionals, propose a synthetic approach of the last progress accomplished in the concerned sectors. The thematic Sessions and the – life of the Academy – resume the communications which, presented in front of the national Academy of pharmacy, are in the heart of the current events.

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