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同时测定孟鲁司特和盐酸非索非那定的稳定性指示高效液相色谱法

Stability-indicating HPLC Method for Simultaneous Determination of Montelukast and Fexofenadine Hydrochloride.

作者信息

Pankhaniya Mona, Patel Parula, Shah J S

机构信息

Department of Quality Assurance, S. J. Thakkar Pharmacy College, Rajkot-360 005, India.

出版信息

Indian J Pharm Sci. 2013 May;75(3):284-90. doi: 10.4103/0250-474X.117426.

DOI:10.4103/0250-474X.117426
PMID:24082344
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3783746/
Abstract

A simple, specific, accurate, and stability-indicating reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of montelukast and fexofenadine hydrochloride, using a Lichrospher(®) 100, RP-18e column and a mobile phase composed of methanol:0.1% o-phosphoric acid (90:10 v/v), pH 6.8. The retention times of montelukast and fexofenadine hydrochloride were found to be 10.16 and 12.03 min, respectively. Linearity was established for montelukast and fexofenadine hydrochloride in the range of 2-10 μg/ml and 24-120 μg/ml, respectively. The percentage recoveries of montelukast and fexofenadine hydrochloride were found to be in the range of 99.09 and 99.81%, respectively. Both the drugs were subjected to acid and base hydrolysis, oxidation, photolytic, and thermal degradation conditions. The degradation products of montelukast and fexofenadine hydrochloride were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of montelukast and fexofenadine hydrochloride in bulk drugs and formulations.

摘要

建立了一种简单、特异、准确且具有稳定性指示功能的反相高效液相色谱法，用于同时测定孟鲁司特和盐酸非索非那定。采用Lichrospher(®) 100 RP - 18e色谱柱，流动相为甲醇:0.1%磷酸(90:10 v/v)，pH 6.8。结果发现孟鲁司特和盐酸非索非那定的保留时间分别为10.16分钟和12.03分钟。孟鲁司特和盐酸非索非那定的线性范围分别为2 - 10μg/ml和24 - 120μg/ml。孟鲁司特和盐酸非索非那定的回收率分别为99.09%和99.81%。对两种药物进行了酸、碱水解、氧化、光解和热降解条件试验。孟鲁司特和盐酸非索非那定的降解产物与纯药物能很好地分离，其保留时间值有显著差异。该方法可成功用于原料药和制剂中孟鲁司特和盐酸非索非那定的同时定量分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/85752d959513/IJPhS-75-284-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/5abf4803ac4d/IJPhS-75-284-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/a32d50e3c8ac/IJPhS-75-284-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/a5246c4ef1a2/IJPhS-75-284-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/0b0f5acd6411/IJPhS-75-284-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/01d216528363/IJPhS-75-284-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/4217d38317f9/IJPhS-75-284-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/85752d959513/IJPhS-75-284-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/5abf4803ac4d/IJPhS-75-284-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/a32d50e3c8ac/IJPhS-75-284-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/a5246c4ef1a2/IJPhS-75-284-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/0b0f5acd6411/IJPhS-75-284-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/01d216528363/IJPhS-75-284-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/4217d38317f9/IJPhS-75-284-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1171/3783746/85752d959513/IJPhS-75-284-g008.jpg

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