高效液相色谱法测定前列通软胶囊中盐酸小檗碱含量

Content Determination of Berberine Hydrochloride in Qianlietong Soft Capsules by High Performance Liquid Chromatography

目的：建立前列通软胶囊中盐酸小檗碱的含量测定方法。方法：采用高效液相色谱法（highpertormanceliquidchromatography，HPI￡），分析柱为VenusilMPC18柱（5μm，4．6mm×250mm），流动相为水（含4．0g／L磷酸和7．0g／L三乙胺）：乙腈（75：25），检测波长为265am，流速为1．0ml／min。结果：盐酸小檗碱浓度在0．0557～0．2787μg／L时与峰面积呈良好的线性关系（r=0．9999），平均回收率为99．67％。结论：HPLC法操作方便，精密度好，准确度高，可作为前列通软胶囊的质量控制方法。

Objective： To establish a high performance liquid chromatography （HPLC） method for content determination of berberine hydrochloride in Qianlietong Soft Capsules. Methods： Venusil MP C18 （5μm,4.6mm×250mm） column was used for the HPLC determination, and the mobile phase consisted of water （4. 0 g/L phosphate and 7.0 g/L triethylamine）-acetonitrile （75： 25） at a flow rate of 1.0 ml/min. The detection wavelength was 265 nm. Results： Berberine bydrochloride had good linear relationship in the range of 0. 0557 A-0. 278 7μg/ml （r=0. 999 9）. The average recovery was 99.67 % （RSD= 1.11%,n=5）. Conclusion： This method is rapid, accurate with good reproducibility, thus it is suitable for quality control of Qianlietong Soft Capsules.