高效液相色谱法测定胆胃胶囊中盐酸小檗碱的含量

Determination of Berberine Hydrochloride in Danwei Capsules by HPLC

目的：制定胆胃胶囊中盐酸小檗碱的含量控制标准。方法：采用高效液相色谱法对方中的盐酸小檗碱进行含量测定，色谱柱为Mltima C18（4．6mm×250mm，5um）；流动相为乙腈-水-磷酸二氢钾-十二烷基硫酸钠（280mL：220mL：1．7g：0．85g）；检测波长345nm；流速1．0mL／min；柱温：35℃。结果：盐酸小檗碱进样量在3．82～38．2μg／mL（r=0．9998）范围内呈良好的线性关系。平均回收率为99．25％（n=9），RSD为0．67％。结论：该方法简便，准确，可用于控制胆胃胶囊的质量。

Objective: To establish an HPLC method for the determination of berberine hydrochloride in Danwei capsules.Methods: HPLC was used to determine the content.The columun was Alltima C18(4.6 mm×250 mm,5um);the mobile phase was acetonitrile-water-KDP-SDS(280ml∶220ml:1.7g:0.85g),with the detection wavelength of 345 nm,at the flow rate of 1.0ml/min and the column temperature at 35℃.Results: The berberine hydrochloride sample showed a good linear relationship at the range of 3.82~38.2μg/ml(r=0.9998).The average recovery rate of adding sample was 99.25%(n=9),RSDwas 0.67%.Conclusion: The method is simple,accurate and can be used for the quality control of Danwei capsules.