UPLC法用于参麦注射液及其中间体的皂苷含量研究

目的：建立超高效液相色谱法（UPLC）同时测定参麦注射液及其中间体中9个人参皂苷含量。 方法：采用WATERS ACQUITY UPLC HSS T3色谱柱（100 mm×2.1 mm，1.8 μm），流动相为乙腈（A）-水（B），梯度洗脱（0~8 min，2%A→10%A；8~16 min，10%A→22%A；16~18 min，22%A→22%A；18~30 min，22%A→46%A；30~36 min，46%A→60%A），流速为0.4 mL· min^-1，检测波长203 nm。 结果：本法可在36 min内完成一次色谱分析，9个主要成分（Rg₁、Re、Rf、Rb₁、Rc、Rb₂、Rb₃、Rd和Rg₃）色谱峰之间具有较好的分离度，回收率在95%~105%之间。 结论：本法能同时测定参麦注射液及5个中间体中9个人参皂苷成分，可检测参麦注射液及中间体的质量，并可为生产企业改善工艺提供参考。

Objective: To establish a UPLC method for simultaneous determination of nine ginsenosides in Shenmai injection and its intermediates. Methods: The chromatographic separation was performed on a WATERS ACQUITY UPLC HSS T3 column(100 mm×2.1 mm,1.8 μm).A gradient elution(0-8 min,2%A→10%A;8-16 min,10%A→22%A;16-18 min,22%A→22%A;18-30 min,22%A→46%A;30-36 min,46%A→60%A) of acetonitrile(A)-water(B) was used with a flow rate of 0.4 mL·min^-1.The detection wavelength was set at 203 nm. Results: The nine ginsenosides (Rg₁,Re,Rf,Rb₁,Rc,Rb₂,Rb₃,Rd and Rg₃) were completely separated within 36 min at one time.High resolution could be achieved among the nine components and the method was linear within the investigated concentration range.The average recovery was between 95% and 105%. Conclusion: The method can simultaneously determine the nine major compounds in Shenmai injection and its five intermediates,which could be applied for overall quality control and can also provide reference for improving the manufacturing process conditions.