Determination of four dry cough medications in fixed dose form by developed stability indicating liquid chromatography-photodiode array detection

IF 17.7 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2024-08-08 DOI:10.1556/1326.2024.01238

J. Saroja, K. Jagadeesh, B. N. Suresh Varma Dendukuri, Rama Swamy Guttula, B. Leela Kumari, C. Chandrashekar

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Abstract

This study deals with the development of HPLC assay method for the determination of guaifenesin (GUF), bromhexine (BRH), chlorpheniramine (CHP), and dextromethorphan (DEE) in bulk and Leekuf tablets. Column C18 Aligent eclipse was used to analyse GUF, BRH, CHP and DEE. The H3PO4 (0.01%) and methanol combined in 70:50 (vol/vol) parts was used as mobile phase. The HPLC assay method was validated in accordance with the ICH prerequisite and was capable of providing accurate (99.90% recovery for BRH, 99.40% recovery for CHP, 100.00% recovery for GUF and 99.50% for DEE) and precise (0.160–0.805% RSD range for GUF, BRH, CHP and DEE) quantitative results under slight variations in chromatographic circumstances in the range of quantities 25–150 μg mL−1 (GUF), 2–12 μg mL−1 (BRH), 0.5–3 μg mL−1 (CHP) and 2.5–15 μg mL−1 (DEE). These results concluded that HPLC assay method developed was beneficial for the evaluation of GUF, BRH, CHP and DEE simultaneously in commercial tablet dose. The degradants eluted are well resolved from the GUF, BRH, CHP, and DEE peaks, showing that the process is stability indicating.

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用已开发的稳定性指示液相色谱-光电二极管阵列检测法测定四种固定剂型的干咳药物

本研究采用高效液相色谱法测定散装和利口药片中的愈创木酚（GUF）、溴己新（BRH）、氯苯那敏（CHP）和右美沙芬（DEE）。使用 C18 Aligent eclipse 色谱柱分析 GUF、BRH、CHP 和 DEE。流动相为 H3PO4（0.01%）和甲醇，体积比为 70:50。该高效液相色谱分析方法按照 ICH 的要求进行了验证，能够提供准确（BRH 的回收率为 99.90%，CHP 的回收率为 99.40%，GUF 的回收率为 100.00%，DEE 的回收率为 99.50%）和精确（GUF 的 RSD 范围为 0.160-0.在 25-150 μg mL-1 (GUF)、2-12 μg mL-1 (BRH)、0.5-3 μg mL-1 (CHP) 和 2.5-15 μg mL-1 (DEE)的量程范围内，在色谱条件稍有变化的情况下，GUF、BRH、CHP 和 DEE 的定量结果均在 0.160-0.805% RSD 范围内。）结果表明，所开发的高效液相色谱分析方法有利于同时评估商品片剂中的 GUF、BRH、CHP 和 DEE。洗脱出的降解剂与 GUF、BRH、CHP 和 DEE 的峰值分辨良好，表明该过程具有稳定性。

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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.