高效液相色谱法测定峰丁麻滴眼剂中盐酸麻黄碱含量

Determination of ephedrine hydrochloride in Fengdingma eye drops by HPLC

目的 建立高效液相色谱法测定蜂丁麻滴眼剂中盐酸麻黄碱含量的方法。 方法 采用YWGC18分析色谱柱 ( 4 6mmID× 2 5 0mm ,粒径 10 μm) ,C18保护柱 ( 4 6mmID× 5mm ,粒径 10 μm) ,流动相 10 %乙腈 ( 0 5 %三乙胺 ,磷酸调pH3 0 ) ,流速 1 0ml/min ,检测波长 2 0 8nm ,测定对照品和样品色谱图 ,记录盐酸麻黄碱色谱峰面积 ,计算其含量。 结果 盐酸麻黄碱的理论板数为 10 0 0 0。回归方程 :y =90 5 878+ 16 15 1738x ,r=0 9999,线性范围 0 4 0 32～ 1 6 13μg。平均回收率为 99 2 % (RSD1 6 % )。 结论 该法操作简便 ,结果准确 。

Objective To develop a quantitative method for the determination of ephedrine hydrochloride (EH) in Fengdingma eye drops by HPLC Methods EH was chromatographed on a YWG C18 column ( 4.6 mm ID×250 mm,10 μm) using a mixture of water and acetonitrile (90∶10, v/v), which was adjusted to pH 3 0 by 0 5% triethylamine solution and phosphoric acid, and monitored at 208 nm with a flow rate of 1 ml/min Results The number of theoretical plates calculated by BH peak was 10 000 The regression equation of BH was Y=905 878+16 151 738X ( r = 0 999 9) , which was linear over a range from 0 4 032 to 1 613 μg The average recovery was 99 2% ( n =5) , RSD was 1 6% Conclusions The method is sensitive, rapid and accurate