HPLC测定小儿清热止咳颗粒中盐酸麻黄碱和盐酸伪麻黄碱的含量

Determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride Contents in Xiao'er Qingre Zhike Granules by HPLC

关键词:  盐酸麻黄碱  盐酸伪麻黄碱  小儿清热止咳颗粒  高效液相色谱法

Key words:  ephedrine hydrochloride  pseudoephedrine hydrochloride  Xiao'er Qingre Zhike granules  HPLC

摘要:

目的 建立用反相高效液相色谱法测定小儿清热止咳颗粒中盐酸麻黄碱和盐酸伪麻黄碱含量的方法。方法 采用ZORBAX SB C₁₈色谱柱，流动相为0.1%磷酸溶液-乙腈(96∶4)，流速为1.0 mL·min^-1，紫外检测波长为205 nm。结果 盐酸麻黄碱线性范围为4.388~43.88 μg·mL^-1(r=0. 999 9)，平均回收率99.7%，RSD为2.1%(n=6)。盐酸伪麻黄碱线性范围为5.300~53.00 μg·mL^-1 (r=0. 999 7)，平均回收率98.5%，RSD为2.8%(n=6)。结论 本法定量准确、重复性好，可作为该制剂的质量控制方法。

Abstract:

OBJECTIVE To establish a HPLC method for the determination of ephedrine hydrochloride and pseudoephedrine hydrochloride contents in Xiao'er Qingre Zhike granules. METHODS Separation was performed on ZORBAX SB C₁₈ column. 0.1% phosphoric acid solution-acetonitrile(96∶4) was selected as the mobile phase, flow rate was set at 1.0 mL·min^-1 and detection wavelength was 205 nm. RESULTS The linear range for ephedrine hydrochloride was 4.388-43.88 μg·mL^-1(r=0. 999 9), the average recovery of ephedrine hydrochloride was 99.7%, RSD=2.1% (n=6). The linear range for pseudoephedrine hydrochloride was 5.300-53.00 μg·mL^-1(r=0.999 7), the average recovery of pseudoephedrine hydrochloride was 98.5%, RSD=2.8%(n=6). CONCLUTION The method is accurate and repeatable, and it can be applied to control the quality of this drug.