Method development and validation of Metformin HCL and Dapagliflozin by using RP-HPLC

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-07-10 DOI:10.1556/1326.2024.01226

Waqar Siddique, Zulcaif, Hassaan Umar, Sufyan Junaid Usmani, Muhammad Waqas, Maria Gul, Mubashra Gul

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Abstract

The prevalence of diabetes is increasing day by day as per a report by the year 2045, 1 out of every 8th individuals may suffer from diabetes. This research article focuses on developing and validating Metformin and Dapagliflozin in combination by using high-pressure liquid Chromatography (RP-HPLC). The validation of the method was followed as per the guidelines provided by the International Conference on Harmonization (ICH) and United States Pharmacopeia (USP). Separation of both drugs takes place in less than 4 min. This separation takes place using Phosphate buffer (pH 6.8) and acetonitrile in a 45:55 (v/v) ratio at a 1.0 mL min−1 flow rate. Furthermore, studies on both drugs were conducted by using the bulk and pharmaceutical dosage forms (Tablets). The developed method was accurate as drug recoveries in both cases of Metformin, and Dapagliflozin ranged between (100.8, 99.6, 98.8%) to (100.8, 99.3, and 101.5%) respectively having a concentration range of solutions between 70, 100 and 130 μg mL−1 dilution. The recommended method for simultaneous quantification of Metformin and Dapagliflozin was established and validated and no excipient interactions were found.

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采用 RP-HPLC 法开发和验证二甲双胍盐酸盐和达帕格列净的方法

糖尿病的发病率与日俱增，据报告，到 2045 年，每 8 个人中就有 1 人可能患有糖尿病。这篇研究文章的重点是利用高压液相色谱法（RP-HPLC）开发和验证二甲双胍和达帕格列净的复方制剂。该方法的验证遵循了国际协调会议（ICH）和美国药典（USP）规定的准则。两种药物的分离过程不到 4 分钟。分离时使用磷酸盐缓冲液（pH 值为 6.8）和乙腈，两者的比例为 45:55（v/v），流速为 1.0 mL min-1。此外，还使用散剂和药物剂型（片剂）对两种药物进行了研究。所开发的方法准确度高，二甲双胍和达帕格列净的回收率分别为（100.8%、99.6%、98.8%）至（100.8%、99.3%、101.5%），溶液的稀释浓度范围为 70、100 和 130 μg mL-1 之间。建立并验证了二甲双胍和达帕格列净同时定量的推荐方法，未发现辅料间的相互作用。

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

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.