Liquid chromatographic determination of mycophenolic acid and its metabolites in human kidney transplant plasma: Pharmacokinetic application

Background and objective: Difference in the hydrophilic properties of mycophenolic acid metabolites makes it technically difficult to simultaneously determine their plasma levels in one analytical run. Therapeutic drug monitoring (TDM) for MPA ensures adequate MPA exposure levels to both prevent rejection and avoid related toxicity. One measure limitation for TDM for MPA is the availability of simple, rapid and reproducible method for determination of MPA derivatives. Method: Herein we report a single method to measure MPA and its metabolites using a gradient elution system in less than 10 min. We further tested applicability of our method in both stable and unstable renal transplant recipients with a wide range of levels. Results: Intra- and inter-day imprecision were less than 8% and 10%, respectively. Accuracy of the estimated concentrations ranges from 90% to 108%. Conclusion: Collectively these data show that the new method is reasonably accurate and precise for the simultaneous determination of MPA and its metabolites in human plasma. (c) 2007 Elsevier B.V. All rights reserved.