复方美沙芬片的HPLC分析

Determination of Dextromethorphan Hydrobromide,Pseudoephedrine Hydrochloride and Chlorpheniramine Meleate in Compound Dextromethorphan Tablets by HPLC

对新药复方美沙芬片中美沙芬、盐酸伪麻黄碱和扑尔敏的ＨＰＬＣ分析进行了研究，考察了流动相组成、ｐＨ等对分离的影响情况。以盐酸萘甲唑啉为内标，检测波长为２６５ｎｍ，在所测范围内，峰面积与被测物浓度的线性关系良好。美沙芬、盐酸伪麻黄碱和扑尔敏平均回收率分别为９３．９２％，９８．７３％和９８．４５％，ＲＳＤ＜１．０２％（ｎ＝５）。

A sensitive and simplified high performance liquid chromatographic procedure was develoed to determine dextromethorphan hydrobromide,pseudoephedrine hydrochloride and chlorpheniramine meleate in Compound Dextromethorphan Tablets.Naphazoline hydrochloride was used as internal standard and the detection wavelength was 265 nm.Effect of the pH of the mobile phase and the proportion of the acenitrileand and methanol in the mobile phase on retention behavior was investigated.The standard curve was linear in the detection range.The proposed method was simple and accurate,and the recoveries were 99.28% for dextromethorphan hydrobromide and 99.40% for pseudoephedrine hydrochloride and 98.49% for chlorpheniramine meleate with RSD less than 1.4%(n=7).