基于UPLC-MS/MS对阿卡波糖和米卡芬净钠中异丙苯磺酸甲酯、异丙苯磺酸乙酯的质量控制

Quality Control of Methyl Isopropylbenzene Sulfonate and Ethyl Isopropylbenzene Sulfonate in Acarbose and Micafungin Sodium Based on UPLC-MS/MS

建立了超高效液相-三重四级杆质谱法(UPLC-MS/MS)测定阿卡波糖和米卡芬净钠中异丙苯磺酸甲酯、异丙苯磺酸乙酯的质量控制方法。以0.01 moL/L甲酸铵水溶液和甲醇为流动相,Agilent Eclipse Plus C18 RRHD(50×2.1 mm 1.8μm)为色谱柱进行梯度洗脱分离,质谱采用正离子多反应监测(MRM)模式采集数据。经验证,该方法线性关系好,检出限低,回收率高,可用于阿卡波糖和米卡芬净钠工艺中异丙苯磺酸甲酯及异丙苯磺酸乙酯的质量控制和工艺优化。

A quality contral method for the determination of methyl isopropyl benzene sulfonate and ethyl isopropyl benzene sulfonate in acarbose and micafungin sodium by ultra performance liquid chromatography triple quadrupole mass spectrometry(UPLC-MS/MS)was established.With 0.01 mol/L ammonium formate aqueous solution and methanol as mobile phase,Agilent Eclipse Plus C18 RRHD(50×2.1 mm 1.8μm)For gradient elution separation of chromatographic column,positive ion multi reaction monitoring(MRM)mode was adopted for mass spectrometry to collect data.The method had good linear relationship,low detection limit and high recovery rate,which could be used for the quality control and process optimization of methyl isopropyl benzene sulfonate and ethyl isopropyl benzene sulfonate in the process of acarbose and micafen sodium.