高效液相色谱-串联质谱法测定人血浆中替加色罗的浓度  

Determination of tegaserod concentrations in human plasma by HPLC-MS/MS

作　　者：刘宁[1] 苏静[1] 黄建权[2] 刘蕾[1] 孙春华[1] 史录文[3] 

机构地区：[1]卫生部北京医院药学部,北京100730 [2]山东大学药学院药物分析研究所,济南250012 [3]北京大学药学院药事管理与临床药学系,北京100083

出　　处：《中国新药杂志》2007年第8期644-647,共4页Chinese Journal of New Drugs

摘　　要：目的：建立人血浆中替加色罗浓度的高效液相色谱一串联质谱测定方法。方法：血浆样本经固相萃取（solid—phaseextraction，SPE）小柱提取处理后进行色谱分离，质谱条件为电喷雾电离源，采用多反应监测（multiplereactionmonitoring，MRM）方式进行定量分析，用于监测的离子为m／z302．1—172．8（替加色罗）和m／z466—183．8（内标，西沙必利）。结果：血浆中替加色罗检测方法的线性范围为0．1—50ng·mL～，最低定量限为0．1ng·mL～。血浆中替加色罗的绝对回收率为99．4％～104．2％，日内及日问精密度分别低于5％和6％，符合生物样品分析要求。结论：本法灵敏，准确，可用于替加色罗的药动学及生物等效性的研究。Objective：To develop a HPLC-MS/MS method for the determination of tegaserod in human plasma. Methods：Plasma samples were prepared by solid-phase extraetion （SPE） followed by a HPLC separation. The samples were subsequently analyzed by a mass spectrum with an ESI source and then quantified by a multiple reaetion monitoring （MRM）. The mass transitions m/z 302.1→172.8 and m/z 466→183.8 were used to trace tegaserod and eisapride （internal standard） , respectively. Results： The calibrated linear curve of tegaserod concentration was in a range of 0.1 to 50 ng.mL^-1. The detec- tion limit was for 0.1 ng.mL^-1. The average recovery rate was 99.4% -104.2%. The within-day and between-day RSD were less than 5.0% and 6.0% , respeetively. Conclusion ：This sensitive and reliable assay can be useful for the analysis of pharmaeokineties and bioequivalenee of tegaserod.

关 键 词：替加色罗 高效液相色谱一串联质谱法 血药浓度 

分 类 号：R972.2[医药卫生—药品]