摘要
目的:建立快速测定人血浆中霉酚酸酯(mycophenolate mofetil,MMF)及其活性代谢物霉酚酸(mycophenolic acid,MPA)浓度的高效液相色谱方法。方法:色谱柱:μBondapak C_(18)(10μm,3.9mm×300mm),流动相:40mmol·L^(-1)TBA-乙腈(65:35),流速:1.0mL·min^(-1),紫外检测波长:254nm,柱温:45℃,血浆样品用2.5倍体积的乙腈沉淀蛋白后直接进样,按内标法定量,内标物选用酰胺咪嗪。结果:MMF 和 MPA 的线性范围分别在:0.2-37.5μg·mL^(-1)和0.56-35.0μg·mL^(-1),最低检测浓度分别为0.10和0.50μg·mL^(-1)。MMF 测定的平均回收率为98.00%-101.0%,日内、日间精密度 RSD 为2.9%-6.7%,MPA 测定的平均回收率为97.88%-101.8%,日内、日间精密度 RSD 分别小于6%和8%。结论:本方法简便快速、定量准确,可用于 MMF 临床药动学研究,也可用于 MPA 血药浓度的常规监测。
Objective:To establish a rapid and feasible HPLC method for the determination of mycophenolate mofetil (MMF) and its active metabolite mycophenolic acid(MPA) in human plasma.Methods:The plasma sample(0.2 mL) was deproteinized with 0.5 mL of acetonitrile and then analyzed on an μBondapak C_(18) (3.9 mm×300mm)col- umn with a 40 mmol·L^(-1) tetrabutyl ammonium bromide (TBA)-acetonitrile (65:35) mobile phase.The flow rate was 1.0 mL·min^(-1),the eluent was detected at 254 nm,the MMF and MPA concentration were obtained by internal standard method,carbamazepine was used as an internal standard.Results:Calibration curves were linear over a concentration range of 0.2-37.5μg·mL^(-1) for MMF,and 0.5-35.0μg·mL^(-1) for MPA.Average recoveries were 98.00%-101.0% for MMF,97.88%-101.8% for MPA.Within-day precision of determination were less than 6% for both MMF and MPA,between-day precision were less than 8%.Conclusion:This method is simple, quick,accurate and can be used for the monitoring of the plasma concentration of MPA routinely and for the study on the clinical pharmacokinetics of MMF.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第4期381-384,共4页
Chinese Journal of Pharmaceutical Analysis
