Stability-indicating green HPLC method for fixed-dose tablets containing remogliflozin etabonate and teneligliptin: an AQbD approach.

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS

ACS Applied Bio Materials Pub Date : 2024-08-01 Epub Date: 2024-09-11 DOI:10.1080/03639045.2024.2400199

Raj Patel, Rajendra Kotadiya

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引用次数: 0

Abstract

Background: In June 2021, the Central Drug Standards Control Organization approved a fixed-dose combination tablet containing remogliflozin etabonate (100 mg) and teneligliptin (10 mg) to manage type II diabetes.

Objective: This study aims to develop a stability-indicating RP-HPLC method for quantifying remogliflozin etabonate and teneligliptin in tablet formulations via analytical quality by design (AQbD) principles.

Methods: Risk assessment, Plackett-Burman design, and central composite design were employed to understand the impact of independent variables on critical analytical attributes. The stationary phase was a HyperClone BDS C18 column, and the mobile phase consisted of acetonitrile and phosphate buffer (20 mM, pH 5) at a 45:55% (v/v) ratio.

Results: The method, validated per ICH Q2 (R1), resulted in retention times of 3.395 and 12.308 min for teneligliptin and remogliflozin etabonate, respectively. Forced degradation studies confirmed robustness, with clear peak separation and no interference from degradation products. The AGREE score of 0.65 supports its green applicability for tablet analysis in quality control.

Conclusion: The AQbD-assisted RP-HPLC method developed in this study offers environmental friendliness, efficient separation with well-defined peaks, and simple mobile phase combination.

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含有依他羧酸雷莫格列净和替尼列汀的固定剂量片剂的稳定性指示绿色高效液相色谱法：AQbD 方法。

背景：2021年6月，中央药品标准管理组织批准了一种含100毫克雷莫格列嗪（remogliflozin etabonate）和10毫克替格列汀（teneligliptin）的固定剂量复方片剂，用于治疗II型糖尿病：本研究旨在通过分析质量设计（AQbD）原则，开发一种指示稳定性的RP-HPLC方法，用于片剂中雷莫格列嗪依他朋酯和替格列汀的定量分析：方法：采用风险评估、Plackett-Burman 设计和中心复合设计来了解自变量对关键分析属性的影响。固定相为 HyperClone BDS C18 色谱柱，流动相为乙腈和磷酸盐缓冲液（20 mM，pH 5），比例为 45:55%（v/v）：根据 ICH Q2 (R1) 方法验证，替格列汀和依他沙坦酯雷莫格列净的保留时间分别为 3.395 分钟和 12.308 分钟。强制降解研究证实了该方法的稳健性，色谱峰分离清晰，没有降解产物的干扰。AGREE 得分为 0.65，证明了其在片剂质量控制分析中的绿色适用性：本研究开发的 AQbD 辅助 RP-HPLC 方法具有环境友好、分离效率高、峰形清晰、流动相组合简单等特点。

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

ACS Applied Bio Materials Chemistry-Chemistry (all)

CiteScore

9.40

自引率

2.10%

发文量

464