HPLC法测定小儿清热止咳口服液中盐酸麻黄碱和盐酸伪麻黄碱的含量

Determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride in Heat Oral Solution for Children by HPLC

关键词:  含量测定  盐酸麻黄碱  盐酸伪麻黄碱  小儿清热止咳口服液  高效液相色谱法

Key words:  content determination  ephedrine hydrochloride  pseudoephedrine hydrochloride  heat oral solution for children  HPLC

摘要:

采用C18色谱柱(4.6 mm×250mm,5μm),以甲醇-0.02mol/L磷酸二氢钠溶液(含0.2%三乙胺,磷酸调pH值2.5,9:91)为流动相,流速1.0ml·min^-1,检测波长210nm,建立反相高效液相色谱法测定小儿清热止咳口服液中盐酸麻黄碱和盐酸伪麻黄碱含量。结果表明,盐酸麻黄碱在0.102~1.02μg范围内与峰面积呈良好线性关系,r=0.9999,平均加样回收率为97.62%,RSD为1.56%(n=6);盐酸伪麻黄碱在0.1016~1.6256μg范围内与峰面积呈良好线性关系,r=0.9999,平均加样回收率为97.55%,RSD为1.84%(n=6)。本方法分离度好,具有良好的重复性,可以同时测定小儿清热止咳口服液中盐酸麻黄碱和盐酸伪麻黄碱的含量。

Abstract:

The HPLC determination method was used to detect the ephedrine hydrochloride and pseudoephedrine hydrochloride in heat oral solution for children by C18 (4.6 mm×250mm, 5μm) and methanol-0.02mol/L sodium dihydrogen phosphate (with 0.2% triethylamine, adjusted with phosphoric acid pH=2.5, 9:91) were used as the mobile phase. The flow was set at 1.0ml·min^-1, and the detection wavelength was 210nm. The precision and stability were fine in those conditions. The calibration curve was linear over the range of 0.102~1.02μg for ephedrine hydrochloride (r=0.9999) and 0.1016~1.6256μg for pseudoephedrine hydrochloride (r=0.9999). The average recovery rates (n=6) was 97.62% for ephedrine hydrochloride and 97.55% for pseudoephedrine hydrochloride. The proposed method can be used in simultaneously quantitative analysis of ephedrine hydrochloride and pseudoephedrine hydrochloride in heat oral solution for children.