固相萃取高效液相法测定复方川贝精胶囊中3种麻黄碱成分的含量

Determination of Three Ephedrine Alkaloids in Compound Chuanbeijing Capsules by SPE-HPLC

目的:建立同时测定复方川贝精胶囊中盐酸麻黄碱、盐酸伪麻黄碱和盐酸甲基麻黄碱含量的方法。方法:采用固相萃取高效液相色谱法,色谱柱为Phenomenex Luna C18(2)柱(150 mm×4.60 mm,5μm),流动相为乙腈-0.1%磷酸溶液(2∶98),检测波长为210 nm,流速为1.0 ml·min-1,柱温为25℃。结果:盐酸麻黄碱、盐酸伪麻黄碱和盐酸甲基麻黄碱的浓度分别在2.0~128.0,0.8~51.2,0.4~9.0μg·ml-1范围内与各自色谱峰面积呈良好线性关系(r=1.0000);盐酸麻黄碱、盐酸伪麻黄碱和盐酸甲基麻黄碱的平均加样回收率分别为98.90%(RSD=0.51%)、98.49%(RSD=0.87%)、97.50%(RSD=1.15%)(n=6)。结论:该方法简便、快速、准确,专属性、重复性良好,可用于复方川贝精胶囊的质量控制。

Objective:To establish an HPLC method with solid-phase extraction(SPE)for the determination of ephedrine hydrochloride,pseudoephedrine hydrochloride and methylephedrine hydrochloride in compound Chuanbeijing capsules.Methods:The determination was performed on a Phenomenex Luna C18(2)(150 mm×4.6 mm,5μm)column with the mobile phase consisting of acetonitrile-0.1%phosphoric acid(2∶98)at a flow rate of 1.0 ml·min-1.The detection wavelength was set at 210 nm and the column temperature was 25℃.Results:The linear relationship of the concentration range was 2.0-128.0μg·ml-1 for ephedrine hydrochloride(r=1.0000),0.8-51.2μg·ml-1 for pseudoephedrine hydrochloride(r=1.0000)and 0.4-9.0μg·ml-1 for methylephedrine hydrochloride(r=1.0000).The average recovery(n=6)was 98.90%(RSD=0.51%)for ephedrine hydrochloride,98.49%(RSD=0.87%)for pseudoephedrine hydrochloride and 97.50(RSD=1.15%)for methylephedrine hydrochloride.Conclusion:The method is simple,rapid,accurate and reproducible with good specificity,which can be applied in the quality control of compound Chuanbeijing capsules.