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建立高效液相色谱-串联质谱(HPLC-MS/MS)法同时测定人血浆中西维来司他及其代谢物(XWIMP-A),并应用于西维来司他在中国健康志愿者体内的药动学研究。血浆采用蛋白沉淀法进行处理后,待测物和内标经Capcell PAK C18色谱柱分离,以5 mmol·L-1醋酸铵水溶液-甲醇-乙腈为流动相进行梯度洗脱。采用电喷雾电离源以多反应监测方式进行负离子检测。测定人血浆中西维来司他和XW-IMP-A的线性范围分别为10.0~15 000 ng·m L-1和2.50~1 000 ng·m L-1,定量下限分别为10.0和2.50 ng·m L-1。待测物日内和日间精密度(RSD)均小于15%,准确度(RE)在±15%之间。本方法成功应用于西维来司他静脉滴注后人体药动学研究。
To establish a simultaneous HPLC-MS / MS method for the simultaneous determination of xvirexinvastatin and its metabolite (XWIMP-A) in human plasma and its application in the treatment of xivelister in Chinese healthy volunteers Pharmacokinetic studies. After the plasma was treated by protein precipitation method, the analytes and internal standard were separated by Capcell PAK C18 column and eluted with 5 mmol·L-1 ammonium acetate-methanol-acetonitrile as mobile phase. Electrospray ionization source is used for negative ion detection by multi-reaction monitoring. The linear range for the determination of cevivistat and XW-IMP-A in human plasma ranged from 10.0 to 15 000 ng · m L-1 and from 2.50 to 1 000 ng · m L-1 with a lower limit of quantitation of 10.0 and 2.50 ng · m L-1. The intra-and inter-day precision (RSD) of the analytes is less than 15% and the accuracy (RE) is between ± 15%. The method was successfully applied to the study of human pharmacokinetics after intravenous administration of.