HPLC一测多评法测定荜铃胃痛颗粒中8种成分的含量

Determination of 8 Active Components in Biling Weitong Granules by HPLC-QAMS

目的:建立高效液相色谱一测多评法(HPLC-QAMS)同时测定荜铃胃痛颗粒中延胡索乙素等8种成分的含量。方法:采用高效液相色谱法,色谱柱:Agilent Eclipse C_(18)(250 mm×4.6 mm,5μm),柱温:30℃;流动相:乙腈-0.1%磷酸水溶液,梯度洗脱;流速:0.9 mL·min^(-1);检测波长分别为215、242和280 nm。以延胡索乙素为内参物,建立其与其他7种成分的校正因子,计算各成分含量。结果:8种成分在各自范围内线性关系良好(r≥0.9991);平均加样回收率及相对标准偏差(RSD)分别为98.74%(1.13%)、99.62%(0.87%)、100.01%(1.06%)、96.91%(1.17%)、99.35%(1.23%)、98.67%(1.32%)、97.60%(0.94%)、98.42%(0.79%);荜铃胃痛颗粒中8个成分含量的高效液相色谱一测多评法结果与外标法(ESM)测得值无明显差异。结论:建立的一测多评法结果准确,可用于荜铃胃痛颗粒的质量控制。

Objective:To establish an HPLC-QAMS method for the determination of 8 active components in Biling Weitong granules.Methods:An HPLC method with an Agilent Eclipse C18(250 mm×4.6 mm,5μm)column was applied,the mobile phase was gradient acetonitrile-0.1%phosphoric acid aqueous solution,the flow rate was 0.9 mL·min^(-1),the column temperature was 30℃.The detection wavelengths were set at 215,242 and 280 nm.Using tetrahydropalmatine as the internal standard,correction factors of the other seven constituents were calculated for content determination.Results:The eight components showed good linear relationships within their own ranges(r≥0.9991),whose average recoveries(RSDs)were 98.74%(1.13%),99.62%(0.87%),100.01%(1.06%),96.91%(1.17%),99.35%(1.23%),98.67%(1.32%),97.60%(0.94%)and 98.42%(0.79%),respectively.No significant difference was found in the quantitative results of the eight components in Biling Weitong granules between the ESM and the HPLC-QAMS methods.Conclusion:The established QAMS method is accurate,which can be used for the quality control of Biling Weitong granules.