Determination of Mycophenolic Acid in Human Plasma by HPLC and Study of Its Pharmacokinetics / 中国药房

ABSTRACT

OBJECTIVE:To establish a HPLC method for the determination of mycophenolic acid (MPA) in human plasma and to study its pharmacokinetics in human body.METHODS:After sedimentation by methanol,plasma sample of MPA was determined directly on Symmetry Shield C18 column with column temperature at 30℃,detective wavelength at 218mn and sample size at 20?L.The mobile phase consisted of acetonitrile-water-triethylamine(40∶60∶0.3) with a flow rate of 1.0mL?min-1.RESULTS:The calibration curve was linear over the range of 0.2～50mg?L-1(r=0.999 6)and the limit of quantitation was 0.2mg?L-1.The mean methodological recovery was 101.94% and the mean extraction recovery was 87.06%.The RSD of both the intra-day and the inter-day were less than 6%.The pharmacokinetic study showed that MPA had enterohepatic circulation in human body,which resulted in the occurrence of double peaks,and the concentration-time curves of MPA were fitted to one-compartment open model.CONCLUSION:This method is sensitive,rapid,specific,accurate and precise,and can be used for the study of pharmacokinetics of MPA.