A novel and rapid LC-MS/MS assay for the determination of mycophenolate and mycophenolic acid in human plasma

Abstract

Objective: The main goal of this research was to develop a simple, rapid and sensitive liquid chromatography/tandem mass spectrometry (LC-MS/ MS) method for the simultaneous quantification of mycophenolate mofetil and mycophenolic acid. Methods: Sample extraction was carried out using a simple solid phase extraction (SPE) technique. The extracted samples were chromatographed on a C18 column using an isocratic mobile phase composed of acetonitrile and 0.1% formic acid buffer (80:20, v/v) pumped at a flow rate of 1.00 mL/min. Results: Method linearity was established in the concentration range of 0.10-20.0 ng/mL for mycophenolate mofetil and 101-19955 ng/mL for mycophenolic acid. Intra-day and inter-day precision and accuracy results of mycophenolate mofetil and mycophenolic acid were well within the acceptance criteria specified in the US FDA and EMEA guidelines. Conclusion: The projected LC-MS/MS assay method is simple, rapid and sensitive for the simultaneous determination of mycophenolate mofetil and mycophenolic acid in human plasma. This method was successfully used to quantitate the in-vivo plasma concentrations obtained from a pharmacokinetic study.