高效液相色谱法测定小儿胃宝咀嚼片中熊果酸含量

Content Determination of the Ursolic Acid in Xiaoerweibao Chewable Tablets by HPLC

目的建立测定小儿胃宝咀嚼片中熊果酸含量的高效液相色谱(HPLC)法。方法色谱柱为Kromasil ODS C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-甲醇-水-醋酸铵(70∶16∶14∶0.5),流速为1.0 m L/min,柱温为室温,检测波长为210 nm。结果熊果酸质量浓度在0.123 6~0.824 0 g/L(r=0.999 5)范围内与峰面积线性关系良好;平均回收率为97.45%,RSD为1.30%(n=5)。结论该法简便易行,灵敏度高,重复性好,可作为小儿胃宝咀嚼片的质量控制方法。

Objective To establish an HPLC method for the content determination of the ursolic acid in Xiaoerweibao Chewable Tablets. Methods The column chromatography was performed on a C18 Kromosil ODS column(250 mm × 4. 6 mm,5 μm). The mobile phase was acetonitrile-methanol-water-acetic acid ammonium(70 :16 :14 :0. 5);the flow rate was 1. 0 mL/min;the column tem-perature was room temperature;the detection wavelength was 210 nm. Results The content had good linear relationship with the peak area in the range of 0. 123 6~0. 824 0 g/L ( r=0. 999 5);the average recovery rate was 97. 45%,and RSD was 1. 30%( n=5). Conclusion The method is simple,sensitive and reproducible,and can be used as the quality control for the Xiaoerweibao Chewable Tablets.