高效液相色谱法测定康妇舒软胶囊中盐酸小檗碱的含量

Quantitative analysis of berberine hydrochloride in traditional Chinese medicine Kangfushu soft capsules by high performance liquid chromatography

目的建立测定康妇舒软胶囊中盐酸小檗碱含量的方法。方法采用高效液相色谱法进行分析,色谱柱为AlltimaC18柱(4.6 mm×250 mm,5μm),以乙腈-0.1%磷酸溶液(50∶50)为流动相,流速1.0 ml/min,检测波长348 nm,柱温40℃。结果盐酸小檗碱在1-10μg/ml(r=0.999 8)范围内线性关系良好,平均回收率为100.46%(RSD=2.34%)。结论所建立的高效液相色谱法操作简单,结果准确,可用于康妇舒软胶囊中盐酸小檗碱的含量测定。

Objective To develop a high performance liquid chromatography（HPLC）method for the determination of berberine hydrochloride in soft capsules of Kangfushu. Methods The HPLC analysis was achieved on Alltima C18 column（250 mm×4.6 mm,5 μm） with a mobile phase of acetonitrile and 0.1% phosphoric acid solution（50∶50） at the flow rate of 1.0 ml/min.The detective wavelength and the column temperature were set at 348 nm and 40 ℃,respectively. Results There was good linearity for berberine hydrochloride between the peak areas and the compound concentrations in the range of 1-10 μg/ml with r=0.999 8.The average recovery was 100.46% with RSD=2.34%. Conclusion The developed HPLC method is a simple and accurate method for quality control of berberine hydrochloride in soft capsules of Kangfushu.