茵栀黄注射液中助溶剂葡甲胺2种含量测定方法比较

Comparison of the determination method of meglumine as cosolvent in Yinzhihuang injection

目的:建立并比较2种测定茵栀黄注射液中助溶剂葡甲胺含量的方法。方法:分别采用高效液相色谱-质谱联用法和亲水相互作用色谱法测定茵栀黄注射液中葡甲胺的含量。液质联用法以氨基葡萄糖为内标,采用Shim-pak VP-ODS(4.6mm×250 mm,5μm)色谱柱,流动相为甲醇-0.1%甲酸溶液(35∶65),大气压化学离子化,选择性正离子方式检测。亲水相互作用色谱法采用Waters XBridge Amide(4.6 mm×150 mm,3.5μm)色谱柱,流动相为甲醇-0.05 mol.mL-1乙酸铵溶液(95∶5),蒸发光散射检测器检测。结果:2种方法测定葡甲胺的线性关系均良好,均具有较强的专属性和重复性,平均回收率分别为100.2%和98.8%。结论:2种方法均可作为茵栀黄注射液中葡甲胺的含量测定方法,但各有优势。

Objective：To establish and compare two methods for determination of meglumine as cosolvent in Yinzhihuang injection.Method：LC-APCI-MS/MS and HILIC-ELSD were utilized to determine the content of meglumine in Yinzhihuang injection respectively.Gglucosamine was used as internal standard in LC-APCI-MS/MS.The separation was carried out on an Shim-pak VP-ODS column（4.6 mm×250 mm,5 μm）with the mobile phase consisted of methanol-0.1% formic acid（35∶65）（v/v）.The detection was performed on a trip-quadrupole tandem mass spectrometer by selected reaction monitoring（SRM） scan mode via atmospheric pressure chemical ionization（APCI）.A Waters XBridge Amide column（4.6 mm×150 mm,3.5 μm）was adopted with mobile phase of methanol-0.05 mol·mL-1 ammonium acetate（95∶5）（v/v） and evaporated light scattering detector was used in HILIC-ELSD.Results：The two methods were all specific and the linear correlation and repeatability were all well for them.The average recovery were 100.2% and 98.8%,respectively.Conclusion：Both methods can be used to control the quality of meglumine as cosolvent in traditional Chinese medicine injections.But each has both advantages and disadvantages.