HPLC测定利胆片的溶出度

Determination of the Dissolution Rate of Cholagogic Tablet by HPLC

目的:建立利胆片中绿原酸溶出度测定方法。方法:150 mL以水为溶出介质,转速100 r.min-1,取样时间60min。采用HPLC,色谱柱C18柱;流动相乙腈-0.05%磷酸(9∶91);检测波长327 nm。测定累积溶出百分率,绘制溶出曲线,并进行样品的溶出度测定。结果:绿原酸浓度在3.288～21.920 mg.L-1有良好的线性关系(r=0.999 7);平均回收率98.88%,RSD 0.44%。不同批次,不同片剂类型的利胆片溶出度差异大,拟定利胆片溶出度控制标准为每片的溶出度以绿原酸(C21H18O11)计,不得少于0.36 mg。结论:该方法简便、可行,重复性好,可用于利胆片质量控制。

Objective： To develop a HPLC method for determination of dissolution rate of chlorogenic acid in Cholagogic tablet. Method： 150 mL of water was used as the dissolution medium, the rotating speed was 100 r min-1 , the sampling time was 60 minutes. The HPLC separation was performed on a Capcell Pak C18 （4.5 mm× 150 mm, 5 μm）, using acetonitrile-0.05% phosphoric acid （9：91 ） as a mobile phase and the detection wavelength was 327 nm. The cumulative dissolution curve was ploted by determinating the cumulative dissolution percentage. Result： The linear range was 3. 288-21. 920 mg .L-1, the average recovery was 98.88% and the RSD was 0.44%. There were considerable dissolution differences of Cholagogic tablet among different batches and types. The content of chlorogenic acid in the single tablet should be no less than 0.36 mg, which was drafted as the quality control standards for the dissolution rate of Cholagogic tablet. Conclusion： The method is simple, viable and reproducible, which can be applied for the quality control of Cho!agogic tablet.