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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 a method for the determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Daqinglongtang granules by HPLC, which can provide the basis for the quality control of this preparation. Methods: The sample was separated on a Zorbax SB-C 18 column (150 mm × 4.6 mm, 5 μm) using acetonitrile-0.02 mol·L -1 potassium dihydrogen phosphate solution containing 0.3% triethylamine Adjusted to pH = 3.0) (5:95) as the mobile phase, flow rate: 1.0 ml · min -1, wavelength: 207 nm. Results: The linear range of ephedrine hydrochloride was 64.64μg · ml -1 (r = 0.999 6), the average recovery was 101.66%, RSD was 2.59% (n = 6) The average recovery was 99.70% and the RSD was 1.58% (n = 6) in the range of ~ 318μg · ml ~ (-1) with a good linear relationship (r = 0.999 7). Conclusion: The method is simple and convenient, accurate and can be used for the quality control of Daqinglongtang granules.