HPLC同时测定美敏伪麻溶液中盐酸伪麻黄碱、马来酸氯苯那敏及氢溴酸右美沙芬的含量Determination of Pseudoephedrine Hydrochloride,Chlorphenamine Maleate and Dextromethorphan Hydrobromide Together in Pseudoephedrine Hydrochloride Chlorphenamine Maleate and Dextromethorphan Hydrobromide Solution by HPLC
陈蓓,翁方海,刘华伟
CHEN Bei,WENG Fanghai,LIU Huawei (TIANDA pharmaceutical(Zhuhai)co.
摘要(Abstract)：
目的建立用HPLC同时测定美敏伪麻溶液中盐酸伪麻黄碱、马来酸氯苯那敏及氢溴酸右美沙芬含量的方法。方法采用色谱柱:HYPERSIL C18(4.6 mm×200 mm,0.5μm),以十八烷基键合硅胶为填充剂。流动相:0.0025 mol.L-1己烷磺酸钠甲醇溶液—水(含1.5%三乙胺)(53∶47)用磷酸调至pH 3.0。检测波长:205 nm;流速:1 m l.m in-1。结果线性范围分别是盐酸伪麻黄碱5.48~274μg.m l-1(r=0.99997,n=5);马来酸氯苯那敏0.43~21.4μg.m l-1(r=1.0000,n=5);氢溴酸右美沙芬1.94~96.8μg.m l-1(r=0.99998,n=5)。结论本法简单、快速、精确、重复性高,可作为产品的质量控制方法。
Objective To establish a HPLC method for the content determination of Pseudoephedrine hydrochloride,Chlorphenamine maleate and Dextromethorphan hydrobromide in Pseudoephedrine hydrochloride chlorphenamine maleate and dextromethorphan hydrobromide solution.Method The separation was performed on HYPERSIL C_(18) column(4.6 mm×200 mm,0.5 μm),the mobile phase was 0.0025 hexanesulfonic acid sodium salt methanolic solution-water(1.5% triethylamine)(53∶47),adjusted with phosphoric acid to pH3.0.The detection wavelength was at 205 nm,the flow rate was 1.0 ml·min~(-1). Result The linearity is in range of 5.48~274 μg·ml~(-1)(r=0.99997,n=5)of Pseudoephedrine hydrochloride,0.43~21.4 μg·ml~(-1)(r=1.0000,n=5)of Chlorphenamine maleate,1.94~96.8 μg·ml~(-1)(r=0.99998,n=5)of dextromethorphan hydrobromide,respectively.Conclusion This method is simple,rapid,accurate and reproducible,and it's suitable for content determination of Rseudoephedrine hydrochloride,Chlorphenamine maleate and Dextromethorphan hydrobromide in Pseudoephedrine hydrochloride Chlorphenamine maleate and dextromethorphan hydrobromide solution.
关键词(KeyWords)：
美敏伪麻溶液;盐酸伪麻黄碱、马来酸氯苯那敏、氢溴酸右美沙芬;高效液相色谱法
Pseudoephedrine hydrochloride chlorphenamine maleate and dextromethorphan hydrobromide solution;pseudoephedrine hydrochloride;chlorphenamine maleate;dextromethorphan hydrobromide;HPLC
基金项目(Foundation):
作者(Author):
陈蓓,翁方海,刘华伟
CHEN Bei,WENG Fanghai,LIU Huawei (TIANDA pharmaceutical(Zhuhai)co.