高效液相色谱法测定丹栀逍遥丸中6个成分的含量

目的： 建立高效液相色谱法测定丹栀逍遥丸中6个化学成分栀子苷、丹皮酚、白芍苷、芍药苷、白术内酯Ⅰ、白术内酯Ⅱ的含量，为其质量控制提供参考。方法： 采用Kromasil 100-5-C₁₈色谱柱（250 mm×4.6 mm，5 μm），流动相为0.3%磷酸水溶液（A）-乙腈（B），梯度洗脱，流速1 mL·min^-1，检测波长230 nm（检测栀子苷、白芍苷、芍药苷、白术内酯Ⅱ）和270 nm（检测丹皮酚、白术内酯Ⅰ），柱温25℃，进样量10 μL。结果： 丹栀逍遥丸中栀子苷、丹皮酚、白芍苷、芍药苷、白术内酯Ⅰ、白术内酯Ⅱ均能达到基线分离，线性关系良好，平均回收率分别为100.1%、100.6%、99.8%、102.6%、98.8%、103.1%，RSD均≤ 2.8%。该方法的精密度、稳定性、重复性良好。3批丹栀逍遥丸中上述6个成分的含量测定结果分别为5.010~5.685、3.130~3.761、5.113~5.697、0.088~0.090、2.448~2.495、0.036~0.041 mg·g^-1。结论： 该方法可用于丹栀逍遥丸中栀子苷、丹皮酚、白芍苷、芍药苷、白术内酯Ⅰ、白术内酯Ⅱ的含量测定，可用于丹栀逍遥丸的质量控制。

Objective: To establish an HPLC method for simultaneous determination of geniposide,paeonol,albiflorin,paeoniflorin,atractylode Ⅰand atractylode Ⅱ in Danzhi Xiaoyao pills,so as to provide reference for its quality control.Methods: Separation was performed on a Kromasil 100-5-C₁₈(250 mm×4.6 mm,5 μm)column.The mobile phase was 0.3% phosphoric acid-acetonitrile at a flow rate of 1 mL·min^-1 with gradient elution.The column temperature was 25℃ and the injection volume was 10 μL.The detection wavelength were set at 230 nm for geniposide,albiflorin,paeoniflorin and atractylodeⅡ,and 270 nm for paeonol and atractylodeⅠ.Results: The six markers reached baseline separation,the linearity was good and the average recoveries were 100.1%,100.6%,99.8%,102.6%,98.8% and 103.1%,respectively with RSDs less than 2.8%.Precision,stability and reproducibility of the method were satisfactory.The contents of the above six components in 3 batches of sample were 5.010-5.685, 3.130-3.761,5.113-5.697,0.088-0.090,2.448-2.495 and 0.036-0.041 mg·g^-1,respectively.Conclusion: The method can be used for the contents determination of six compounds in Danzhi Xiaoyao pills,and can be used for the quality control of Danzhi Xiaoyao pills.

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