UPLC-MS/MS法测定中成药制剂中添加的11种降压药物

Determination of 11 Antihypertensive agents in Chinese patent medicine by UPLC-MS/MS

目的建立一种UPLC-MS/MS条件下同时对中成药制剂中非法添加的11种降压类药物进行快速、准确、灵敏测定的方法。方法采用超高效液相色谱-串联点喷雾四极杆质谱,在多反应监测(MRM)模式下测定中成药胶囊剂、片剂及丸剂中11种降压药物的含量。结果在本实验条件下11种降压药物在0.025μg/m^5.000μg.mL-1范围内线性良好,最低检出浓度为0.05ng.mL-1~1.5ng.mL-1,添加水平为0.128~1.28μg.mL-1时,平均加标回收率在67.22%~119.26%之间。结论所建立的方法能同时对添加的多种降压药物进行定性及定量分析,方法精密度较好、准确度较高,可作为检测中成药中非法添加降压药物的有效方法。

OBJECTIVE A rapid, accurate and sensitive method for simultaneous determination of 11 antihy- pertensive agents in Chinese patent medicine is set up. METHODS Ultra performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry （UPLC-MS/MS） was applied.The analysis was performed using the multiple reaction monitoring in which 11 antihypertensive agents added in different formulation types were detected. RESULTS The Linear range is from 0. 025μg. mL^-1 to 5. 000μg. mL^-1 which shows a good correlation.The average recoveries for adding standards are from 67.22% to 119.26%, and the detection limits vary from 0.05 ng. mL^-1 to 1.5 ng. mL^-1 CONLUSION The analytical method in the present study was well validated and good results were obtained with respect to precision, repeatability and spiked recovery, so it can be used for determination of antihypertensive agents mixed in Chinese patent medicine.