高效液相色谱法同时测定霉酚酸酯及霉酚酸的血药浓度  

Simultaneous determination of the concentration of mycophenolate mofetil and mycophenolic acid in plasma by HPLC

作　　者：朱顺海[1] 赵梦芸 陈佳 许志良[1] 

机构地区：[1]浙江中医药大学基础医学院,杭州310053 [2]中科(杭州)生命科学院有限公司,杭州310052

出　　处：《上海医药》2015年第7期77-80,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的 ：建立高效液相色谱法同时测定人体血浆中霉酚酸酯及霉酚酸的药物浓度。方法 ：血浆样品经乙腈沉淀蛋白后直接进样,采用Zorbax SB-C18（4.6 mm×250 mm,5 mm）的色谱柱,流动相为0.3%的三乙胺水溶液（用磷酸调节p H 5.3）-乙腈（50∶50）。检测波长为215 nm,柱温35℃,流速1.0 ml/min。结果 ：本方法测定的线性范围为0.25~20 mg/ml,r（霉酚酸）=0.999 76,r（霉酚酸酯）=0.99999。霉酚酸和霉酚酸酯的加标回收率分别为（87.38±2.97）%和（99.71±1.18）%,最低检出限分别为0.035 mg/ml和0.070 mg/ml（S/N=3）。结论 ：本方法简单,灵敏,重现性好,适合器官移植等患者霉酚酸及霉酚酸酯的血药浓度监测,以及霉酚酸酯的药代动力学研究。Objective： To establish an HPLC method for simultaneous determination of the concentrations of mycophenolate mofetil and mycophenolic acid in human plasma. Methods： The plasma sample was analyzed by HPLC on a Zorbax SB-C18 column（4.6 mm×250 mm,5 mm） with 0.3% aqueous triethylamine- acetonitrile（50：50） as a mobile phase at the detection wavelength of 215 nm, column temperature of 35 ℃ and flow velocity of 1.0 ml/min after the proteins were precipitated out by acetonitrile. Results： The standard curve was linear over the range of 0.25 ~10 mg/ml with r（MPA）=0.99976, r（MMF）=0.999 99. The recoveries of MPA and MMF were（87.38±2.97） % and（99.71±1.18） % and the limit of detection for MPA and MMF were 0.035 mg/ml and 0.070 mg/ml（S/N=3）. Conclusion： This method is simple, sensitive, reproducible, and suitable for the monitoring of the concentrations of mycophenolic acid and mycophenolate mofetil in patients with organ transplantation and the pharmacokinetic study of mycophenolate mofetil.

关 键 词：霉酚酸酯 霉酚酸 血药浓度 高效液相色谱法 药代动力学 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]