HPLC法测定复方金沙利胆颗粒中芍药苷的含量

Determination content of Paeoniflorin in Fufang Jinsha Lidan Keli by HPLC

目的建立复方金沙利胆颗粒中芍药苷的含量测定方法及质量控制研究。方法色谱柱为We Lch Utimate XB-C_(18)(4.6 mm×250 mm,5μm),流动相:乙腈-纯水(17∶83),流速1.0 m L·min^(-1),柱温室温,检测波长230 nm,进样量20μL。用高效液相色谱法对芍药苷进行定量测定;对主要成分黄芩、白芍、枳壳等进行薄层鉴别。结果用该方法定性鉴别专属性强,芍药苷在浓度3.92~98μg·m L^(-1)内呈现良好的线性关系(r=0.9995)。芍药苷平均回收率为98.11%,RSD为1.10%(n=6)。结论该方法简便,准确,重现性好,分离度好,回收率高,能有效对复方金沙利胆颗粒的质量进行控制和评价。

Objective To establish the determination method for the content of paeoniflorin in Fufang Jinsha Lidan Keli and the standard for the quality control of Fufang Jinsha Lidan Keli. Methods The analysis was performed on a Welch Utimate XB-C_（18）（ 4. 6 mm × 250 mm,5 μm）column. The mobile phase was acetonitrile and water（ 17∶ 83） at a flow rate of 1. 0 m L·min^-1. The column temperature was room temperature and the detection wavelength was 230 nm. The injection volume was 20μL. Scutellaria baicalensis Georgi,Cynanchum otophyllum and Fructus aurantii were identified qualititatively by Thin—Layer Chromatography（ TLC）. Paeoniflorin in Fufang Jinsha Lidan Keli were determined by HPLC. Results The TLC spots were highly clear without the interference of negative control. The calibration curve for Paeoniflorin was linear（ r =0. 9995） in the range of 3. 92 ~ 98. 00 μg·m L^-1. And the mean recovery was 98. 11%. RSD was 1. 10%（ n = 6）. Conclusion This method is accurate,simple,sensitive and reliable and it can be used for the quality control of Fufang Jinsha Lidan Keli.