HPLC法测定复方五指柑胶囊中盐酸小檗碱的含量

HPLC Determination of Berberine Chloride in Compound Wuzhigan Capsules

目的通过测定复方五指柑胶囊中盐酸小檗碱的含量,为其质量控制提供稳定、可靠的测定方法。方法采用高效液相色谱法,Diamonsil ODS(250mm×4.6mm,5μm)色谱柱,流动相为乙腈-0.033mol/L磷酸二氢钾水溶液(30∶70),流速1.0mL/min,检测波长347nm,柱温30℃。结果盐酸小檗碱在2.52～12.6μg/mL范围与峰面积呈良好的线性关系,该制剂中的盐酸小檗碱平均含量为1.686mg/粒。结论本法简便、准确,可作为该制剂含量控制方法。

Objective To determinate BerberLne chloride in compound Wuzhigan capsules and develop a steady and reliable method for the quality control of the capsules. Methods A HPLC method was adopted. The column was Diamonsil C18 （250 mm×4,6 mm, 5 pro） with the column temperature of 30 ℃, the mobile phase was acetonitrile-0.033 mol/L potassium dihydrogen phosphate （30 ： 70） with the flow rate of 1.0 mL/min, and the detection wavelength was at 347 nm. Results Berbefine chloride has a linearity in the range of 2.52-12.6 μg/mL, and the average content in the capsules was 1.686 mg/capsules. Conclusion This method is sample, accurate, and can be used for the quality control of compound Wuzhigan capsules.