HPLC法测定盐酸氨溴索缓释片的含量

Content determination of Ambroxol hydrochloride Sustained-Release Tablets by HPLC

目的:建立高效液相法测定盐酸氨溴索缓释片含量的方法。方法:采用HypersilODS-2(4.6mm×150mm,5μm)色谱柱;流动相:乙腈-甲醇-0.01mol/L磷酸盐缓冲液(pH=3.0)(20:40:40);流速:1.0ml/min,检测波长:254nm。结果:盐酸氨溴索在0.244～4.880μg范围内与峰面积呈良好的线性关系(r=0.9996),平均回收率为99.70%,RSD=0.33%(n=9)。结论:本方法简便、灵敏、准确,可用于盐酸氨溴索缓释片的质量控制。

Objective： To establish a method for the content determination of ambroxol hydrochloride in Ambroxol Hy- drochloride Sustained-Release Tablets by HPLC. Methods： The Hypersil ODS-2 （4.6 mm×150 mm, 5 μm） column was used. The mobile phases consisted of acetonitrile, methanol and 0.01mol/L phosphoric acid （pH=3.0） （20：40：40）, the flow rate was 1.0 ml/min and the detection wavelength was at 245 nm. Results： The linear ranges of Diphenhydramine Hy- drochloride was at 0.244-4.880 μg（r=-0.999 6）, the average recovery was 99.70% with a RSD of 0.33% （n=9）. Conclusion： The method is fast, reliable, accurate and can be used in the quality control of ambroxol hydrochloride in Ambroxol Hy- drochloride Sustained-Release Tablets.