HPLC法同时测定氨麻苯美片中4种主要成分的含量  

Simultaneous HPLC determination of four main ingredients in Anmabenmei tablets

作　　者：张云楚[1] 王玉[1] 纪宇[1] 石蓓佳[1] 崔屹[2] 刘秀娟 

机构地区：[1]江苏省药品检验所,南京210008 [2]中国药科大学,南京210009 [3]拜尔医疗保健启东工厂,启东226200

出　　处：《药物分析杂志》2011年第6期1158-1161,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立同时测定氨麻苯美片中盐酸伪麻黄碱、对乙酰氨基酚、氢溴酸右美沙芬和盐酸苯海拉明等成分含量的HPLC方法。方法：色谱柱为Kromasil 60-5CN（25 mm×4.6 mm,5μm）柱;以乙腈-pH3.0的40 mmol.L-1三乙胺水溶液（20∶80）为流动相;检测波长为215 nm;流速为1.0 mL.min-1。结果：盐酸伪麻黄碱、对乙酰氨基酚、氢溴酸右美沙芬和盐酸苯海拉明的线性范围分别为6.036~150.9μg.mL-1（r=1.0000）,65.42~1636μg.mL-1（r=0.9989）,3.010~75.25μg.mL-1（r=1.0000）,50.90~127.2μg.mL-1（r=1.0000）;加样回收率（n=9）分别为98.5%,100.9%,99.1%和99.6%。结论：本法简单、快速、准确,可用于氨麻苯美片中4种主要成分的同时测定。Objective：To establish an HPLC method to determinate the four main ingredients in Anmabenmei tablets.Method：The separation was performed on Kromasil 60-5CN（250 mm×4.6 mm）,using the mixture of acetonitrile-water（containing 40 mmol·L-1 triethylamine,pH adjusted to 3.0 with orthophosphoric acid）（20∶80）） as the mobile phase with the flow rate of 1.0 mL·min-1.Detection wavelength was at 210 nm.Result：The linearity ranges and the recoveries for pseudoephedrine hydrochloride,paracetamol,diphenhydramine hydrochloride and dextromethorphan hydrobromide were 6.036-150.9 μg·mL-1（r=1.0000）,65.42-1636 μg·mL-1（r=0.9989）,3.010-75.25 μg·mL-1（r=1.0000）,50.90-127.2 μg·mL-1（r=1.0000） and 98.5%,100.9%,99.1% and 99.6%,respectively.Conclusion：This method is simple,rapid and accurate,and could be used to determine the four main ingredients in paracetamol,pseudoephedrine hydrochloride,diphenhydramine hydrochloride and dextromethorphan hydrobromide tablets.

关 键 词：对乙酰氨基酚 氢溴酸右美沙芬 盐酸苯海拉明 盐酸伪麻黄碱 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]