HPLC法同时测定复方氨茶碱口服液中氨茶碱和盐酸麻黄碱的含量

Simultaneous determination of aminophylline and ephedrine hydrochloride in complex aminophylline oral solution by HPLC

目的:建立高效液相色谱同时测定复方氨茶碱口服液中氨茶碱和盐酸麻黄碱含量的方法。方法:色谱柱C_(?)柱,流动相为乙腈-磷酸二氢钾缓冲液(pH 4.5)(10:90,V/V),检测波长214 nm,流速0.8 mL/min,检测氨茶碱浓度和盐酸麻黄碱浓度。结果:氨茶碱浓度在20.0～500.0μg/mL,盐酸麻黄碱浓度在2.0～50.0μg/mL范围内线性良好,氨茶碱和盐酸麻黄碱的平均回收率分别为99.7%(RSD=0.58%)、100.1%(RSD=1.31%),n=9。结论:该法简单、灵敏、准确,可用于该复方制剂的质量控制。

Objective ： To establish a method to simultaneously determine aminophylline and ephedrine hydrochloride in complex aminophylline oral solution by HPLC. Methods： C18 column was used. The mobile phase was acetonitrile-phosphate buffer （pH 4.5） （10：90, V/V） and the flow rate was 0.8 mL/min. The detect UV wavelength was 214 nm. Results： The linear range was 20.0 - 500.0 μg/mL and 2.0 - 50.0 μg/mL for aminophylline and ephedrine hydroehlofide, respectively ; the average recovery were 99.7 % （ RSD = 0.58 % ） and 100.1% （ RSD = 1.31% ）, n = 9. Conclusions ： The method was found to be simple, sensitive and accurate. The study provides a practicable method of quality control for the preparation.