高效液相色谱法测定痔速宁片中没食子酸含量

Determination of Gallic Acid in Zhisuning Tablets by HPLC

目的建立测定痔速宁片中没食子酸含量的高效液相色谱法。方法色谱柱为Krosima C18柱(250mm×4.6mm,5μm),流动相为甲醇-冰乙酸-N,N二甲基酰胺-水(2:1:40:157),柱温为室温,流速为0.5mL/min,检测波长为275nm。结果没食子酸进样量在0.084～0.420μg范围内与峰面积线性关系良好,r=0.9999;平均回收率为98.08%,RSD为1.16%(n=6)。结论所用方法简便、准确,灵敏度高,重现性好,可作为痔速宁片质量控制的方法。

Objective To establish an RP-HPLC method for the content determination of gallic acid in Zhisuning Tablets.Methods The separation was performed on the Krosima C18 column（250 mm × 4.6 mm,5 μm） with the mobile phase of methanol-HAc-N,N-dimethylformamid-water（2：1：140：157）.The temperature was room temperature,the flow rate was 0.5 mL /min.The UV detection wavelength was 275 nm.Results The linear range of gallic acid was in the range of 0.084-0.420 μg,r = 0.999 9.The mean recovery rate was 98.08%,RSD was 1.16%（n = 6）.Conclusion This method is simple and accurate with high sensitivity and good reproducibility,which can be used to control the quality of Zhisuning Tablets.