使用曙红 Y 测定盐酸溴己新及其活性代谢物盐酸氨溴索的简便方法。

Facile approaches for determination of Bromhexine Hydrochloride and its active metabolite Ambroxol Hydrochloride using Eosin Y.

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Mansoura University, 35516 Mansoura, Egypt.

出版信息

Ann Pharm Fr. 2022 Sep;80(5):687-696. doi: 10.1016/j.pharma.2021.12.004. Epub 2021 Dec 27.

DOI:10.1016/j.pharma.2021.12.004

Abstract

New validated Spectroscopic methods were developed to assay Bromhexine Hydrochloride and its active metabolite Ambroxol Hydrochloride separately in pure form and pharmaceutical formulations. The spectrophotometric assay (method I) shows complex formation between each of the drugs and Eosin Y at 540nm at pH 3.6 and 3.4mL of 4×10M Eosin for Bromhexine and Ambroxol. The Spectrofluorimetric assay (method II) depends on quenching eosin native fluorescence by the studied drugs, which measured at 540nm after excitation at 302nm. The spectrophotometric absorbance-concentration plot is rectilinear over the ranges (1.0-5.0) and (1.0-10.0) μg/mL for bromhexine and ambroxol with LOD of 0.31 and 0.14μg/mL and LOQ of 0.94 and 0.42μg/mL for the two drugs respectively. The fluorometric-concentration plot is linear along the range (1.0-5.0) μg/mL and (1-10) μg/mL for the two drugs respectively with LOD of 0.13μg/mL and 0.22μg/mL and LOQ of 0.4μg/mL and 0.65μg/mL for the two drugs, respectively. Developed assays have been validated in agreement with ICH recommendations and they were used in the analysis of commercial drug formulations containing the two mucolytic drugs and the results were matching with those obtained by the comparison method.

摘要

新开发的光谱方法被用于分别测定盐酸溴己新及其活性代谢物盐酸氨溴索在纯品和制剂中的含量。分光光度法（方法 I）显示，在 pH 3.6 时，两种药物与曙红 Y 在 540nm 处形成络合物，对于溴己新和氨溴索，需要 3.4mL 的 4×10M 曙红 Y。荧光光谱法（方法 II）依赖于研究药物对曙红天然荧光的猝灭，在 302nm 激发后在 540nm 处测量。分光光度法的吸光度-浓度曲线在（1.0-5.0）和（1.0-10.0）μg/mL 范围内对于溴己新和氨溴索是线性的，LOD 分别为 0.31 和 0.14μg/mL，LOQ 分别为 0.94 和 0.42μg/mL。荧光法的浓度曲线在（1.0-5.0）μg/mL 和（1-10）μg/mL 范围内对于两种药物分别是线性的，LOD 分别为 0.13μg/mL 和 0.22μg/mL，LOQ 分别为 0.4μg/mL 和 0.65μg/mL。所开发的测定方法已经按照 ICH 建议进行了验证，并用于分析含有两种黏液溶解药物的商业药物制剂，结果与比较法获得的结果相匹配。