HPLC法测定独一味制剂中山栀苷甲酯

Determination of Shanzhiside Methylester in Preparations of Lamiophlomis Rotata by HPLC

目的:建立独一味制剂中山栀苷甲酯的HPLC测定方法,为进一步控制独一味制剂的质量提供良好的参考。方法:采用HPLC反向色谱柱Symmetry C18(4.6mm×150mm,5μm),梯度洗脱,0～9min乙腈-水(9∶91),9～20min乙腈-水(15∶85),流速1.0mL·min-1,柱温20℃,检测波长235nm。结果:山栀苷甲酯浓度在9.6～115.2μg·mL-1范围内与峰面积积分值线性关系良好;加样回收率为97.69%。从所有的制剂中均检测出山栀苷甲酯,但含量差别较大。结论:该方法准确、简便、专属性强、重现性好,适用于独一味制剂中山栀苷甲酯的含量测定。

Objective：To establish a HPLC method for the determination of shanzhiside methylester in the preparations of Lamiophlomis rotata.Method：HPLC analysis was performed on Symmetry C 18（5μm） column and gradient elution0-9 min,acetonitrile-water（9∶91） ,9-20 min,acetonitrile-water（15∶85） was used as the mobile phase at a flow rate of 1.0 ml·min^-1 .The column temperature was 20℃and the detection wavelength was at 235 nm.Result：The linear range of shanzhiside methylester was 9.6～115.2μg·mL^-1（r=0.999 8） and the average recovery was 97.69%.Shanzhiside methylester could be detected from all preparations and the content variedgreatly.Conclusion：The method can be applied to determine the content of shanzhiside methylester in the preparations of L.rotata.