反相高效液相色谱法研究乙胺丁醇的强制降解

Q4 Pharmacology, Toxicology and Pharmaceutics

INDIAN DRUGS Pub Date : 2023-08-28 DOI:10.53879/id.60.08.13714

V. Bhusari, Utkarsh S. Bhosale, Nikita K. Jagtap, M. Ghante

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引用次数: 0

摘要

对乙胺丁醇的文献调查显示，无论是散装还是药物剂型，都没有稳定性表明分析方法被报道用于估计。因此，需要开发和验证一种稳定性指示分析方法。本研究建立了反相高效液相色谱法分离乙胺丁醇及其降解产物。乙胺丁醇暴露于水解、氧化、中性(水)和光解分解等应激源下，降解产物使用ODS Hypersil C-18色谱柱分离。缓冲液:以乙腈为流动相，流速为0.5 mg mL-1。乙胺丁醇的保留时间为6.1 min。根据ICH Q2(R1)规定的指南进行验证研究。制药工业可以使用开发的方法对药物剂型进行常规药物分析。

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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FORCED DEGRADATION STUDIES FOR ETHAMBUTOL BY RP-HPLC

Literature survey of ethambutol reveals no stability indicating analytical method being reported for estimation, either in bulk or in a pharmaceutical dosage form. Therefore, a stability indicating analytical method needed to be developed and validated. In the current research, a RP-HPLC method was developed to separate ethambutol from its degradation products. Ethambutol is exposed to stressors like hydrolysis, oxidation, neutral (water), and photolysis decomposition, and the degradation products were separated using an ODS Hypersil C-18 column. Buffer: acetonitrile was used as mobile phase at a flow rate of 0.5 mg mL-1. Ethambutol showed a retention time of 6.1 min. Validation study was performed as per guidelines prescribed by ICH Q2(R1). Pharmaceutical industries can use the developed method to perform routine drug analysis on pharmaceutical dosage forms.

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来源期刊

INDIAN DRUGS Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

0.30

自引率

0.00%

发文量