高效液相色谱法测定胃安胶囊中盐酸小檗碱含量

Determination of Berberine Hydrochloride in Weian Capsule by HPLC

目的建立测定复方制剂胃安胶囊中盐酸小檗碱含量的高效液相色谱法。方法色谱柱为C18柱(250mm×4.6mm,5μm),以0.02mol/L磷酸二氢钾溶液(以磷酸调pH至3.0)-乙腈(65∶35)为流动相,检测波长348nm。结果盐酸小檗碱进样量在0.040～2.022μg范围内与峰面积线性关系良好,r=0.9999,平均回收率为95.16%,RSD为2.12%(n=9)。结论所用方法准确、可靠,精密度高,适于复方制剂胃安胶囊的质量控制。

Objective To establish a method for determining berberine hydrochloride in Weian Capsule.Methods The C18 column was used,with 0.02 mol/L potassium dihydrogen phosphate buffer solution （adjusted to pH 3.0 with H3PO4）-acetonitrile （65 ∶35） as the mobile phase,and the detection wavelength was 348 nm.Results The calibration curve of berberine hydrochloride was linear in the range of 0.040-2.022 μg with r=0.999 9.The average recovery rate was 95.16%with RSD of 2.12%（n=9）.Conclusion This method is proved to be accurate and acceptable,which can be selected to control the quality of compound Weian Capsule preparations.