高效液相色谱法同时测定清肝益脾胶囊中靛蓝和靛玉红含量

Simultaneous Determination of Indigo and Indirubin in Qinggan Yipi Capsules by HPLC

目的建立同时测定清肝益脾胶囊中靛蓝和靛玉红含量的高效液相色谱法。方法色谱柱为Hypersil ODS柱(250 mm×4.6 mm,25μm),流动相为甲醇-水(70∶30,V/V),流速为1.0 mL/min,检测波长为290 nm,柱温为30℃,进样量为10μL。结果靛蓝和靛玉红质量浓度分别在7.63~122.00μg/mL、5.00~80.00μg/mL范围内与峰面积线性关系良好(R^(2)≥0.9998);精密度、稳定性、重复性试验结果的RSD均小于3.0%;平均加样回收率分别为96.93%和98.40%,RSD分别为1.36%和1.42%(n=6)。结论所建立的方法简便,结果准确,重复性好,可用于清肝益脾胶囊的质量控制。

Objective To establish the high-performance liquid chromatography(HPLC)method for the simultaneous determination of indigo and indirubin in Qinggan Yipi Capsules.Methods The chromatographic column was Hypersil ODS column(250 mm×4.6 mm,25μm),the mobile phase was methanol-water(70∶30,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 290 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The linear ranges of indigo and indirubin were 7.63-122.00μg/mL and 5.00-80.00μg/mL respectively(R^(2)≥0.9998).The RSDs of precision,stability and repeatability tests were all lower than 3.0%.The average recovery rates of indigo and indirubin were 96.93%and 98.40%respectively,with RSDs of 1.36%and 1.42%respectively(n=6).Conclusion The established method is simple,accurate and repeatable,which can be used for the quality control of Qinggan Yipi Capsules.