HPLC法同时测定氨麻苯美片中4种主要成分的含量

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,5 μm)柱;以乙腈-pH 3.0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6.036~150.9 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);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.