Development and validation of stability indicating RP-HPLC method for determination of aspirin and pantoprazole sodium in synthetic mixture stability indicating HPLC method

International Journal of Pharmaceutical Chemistry and Analysis Pub Date : 2023-04-15 DOI:10.18231/j.ijpca.2023.006

Preetiben N. Yadav, Pinak Patel, Rashmi Shukla, Krunal Detholia, Anamika Singh

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Abstract

The present study describes a new accurate and precise stability indicating reverse phase HPLC method for quantitative computation of pantoprazole sodium and Aspirin from physical simulated mixture. The proposed chromatographic method employs Hypersil ODS C18 column (250 x 4.6 mm, 5μ) as the stationary phase and combination of methyl alcohol and water in ratio of 70: 30 v/v as the elution medium. Overall separation was carried out at 0.8 ml/minute flow rate and elution was monitored at 254 nm. The proposed system gave well resolved peak of Aspirin and Pantoprazole sodium with elution time of 2.32 and 5.85 minute respectively. Same system was effective in separation of active components and degradation products when the components were subjected to forced degradation as per regulatory guidelines (ICHQ1). Finally, the optimized method was successfully validated as per ICH Q2R1 guidelines and applied for quantitative analysis of both active components in synthetic mixture.

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稳定性指示反相高效液相色谱法测定合成混合物中阿司匹林和泮托拉唑钠的含量

本文建立了一种准确、精确、稳定性指示的反相高效液相色谱方法，用于物理模拟混合物中泮托拉唑钠和阿司匹林的定量计算。采用Hypersil ODS C18色谱柱(250 × 4.6 mm, 5μ)为固定相，甲醇与水以70:30 v/v的比例混合为洗脱介质。以0.8 ml/min的流速进行整体分离，在254 nm处监测洗脱。洗脱时间分别为2.32 min和5.85 min，得到了较好的阿司匹林和泮托拉唑钠的分离峰。当组分按照法规指南(ICHQ1)进行强制降解时，同一系统在分离活性组分和降解产物方面是有效的。最后，根据ICH Q2R1指南成功验证了优化后的方法，并应用于合成混合物中两种有效成分的定量分析。

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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International Journal of Pharmaceutical Chemistry and Analysis

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