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

IF 1.7 4区化学 Q3 CHEMISTRY, ANALYTICAL

Acta Chromatographica 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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引用次数: 0

摘要

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

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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来源期刊

Acta Chromatographica 化学-分析化学

CiteScore

4.00

自引率

0.00%

发文量

审稿时长

2.3 months

期刊介绍： Acta Chromatographica Open Access Acta Chromatographica publishes peer-reviewed scientific articles on every field of chromatography, including theory of chromatography; progress in synthesis and characterization of new stationary phases; chromatography of organic, inorganic and complex compounds; enantioseparation and chromatography of chiral compounds; applications of chromatography in biology, pharmacy, medicine, and food analysis; environmental applications of chromatography; analytical and physico-chemical aspects of sample preparation for chromatography; hyphenated and combined techniques; chemometrics and its applications in separation science.