HPLC法测定大青龙汤颗粒剂中盐酸麻黄碱和盐酸伪麻黄碱的含量

Determination of Ephedrine and Pseudoephedrine in Daqinglong Tang Granules by HPLC

目的:建立HPLC测定大青龙汤颗粒剂中盐酸麻黄碱和盐酸伪麻黄碱含量的方法,为该制剂的质量控制提供依据。方法:采用Agilent Zorbax SB-C_(18)色谱柱(150 mm×4.6 mm,5μm),以乙腈-含0.3%三乙胺的0.02 mol·L^(-1)磷酸二氢钾溶液(用磷酸调节至pH=3.0)(5:95)为流动相,流速:1.0 ml·min^(-1),波长:207 nm。结果:盐酸麻黄碱在64～640μg·ml^(-1)浓度范围内线性关系良好(r=0.999 6),平均回收率为101.66%,RSD为2.59%(n=6);盐酸伪麻黄碱在31.8～318μg·ml^(-1)浓度范围内呈现良好的线性关系(r=0.999 7),平均回收率为99.70%,RSD为1.58%(n=6)。结论:该法简便易行,结果准确,可用于大青龙汤颗粒剂的质量控制。

Objective： To establish an HPLC method for determining ephedrine hydrochloride and pseudoephedrine hydrochioride in Daqinglong Tang granules to provide the basis for the quality control. Method： The Agilent Zorbax SB C18 column （150 mm × 4.6 mm, 5 μm） was used and the mobile phase was acetonitrile-0.02 mol · L^-1 KH2PO4 （containing 0.3% triethylamine, adjusting pH to 3.0 with phosphoric acid） （5： 95）. The flow rate was 1.0 ml ·min^-1 and the detection wavelength was at 207 nm. Result： The calibration curve was linear within the range of 64-640 μg · ml^-1 for ephedrine hydrochloride （ r = 0.999 6） and the average recovery was 101.66% with RSD of 2.59% （n = 6）. The calibration carve was linear within a range of 318-31.8 μg · ml ^-1 for the pseudo- ephedrine hydrochtoride （r = 0. 999 7） and the average recovery was 99.70% with RSD of 1.58 % （ n = 6）. Conclusion ： The method is simple and accurate, and can be used for the quality control of Daqinglong Tang granules.