A novel and Rapid LC–MS/MS assay for the Determination of Mycophenolate and Mycophenolic Acid in Human Plasma

    Published on:November 2016
    Journal of Young Pharmacists, 2017; 9(1):106-113
    Original Article | doi:10.5530/jyp.2017.9.20

    Rambabu Maddela1,2, Nageswara Rao Pilli1,2, Srinubabu Maddela1, Chalapathi Rao Pulipati2, Srinivasa Rao Polagani2, Ajitha Makula1*

    1Department of Pharmaceutical Analysis, Center for Pharmaceutical Sciences, Jawaharlal Nehru Technological University Hyderabad, Kukatpally, Hyderabad–500 085, INDIA.

    2 Department of Bioanalysis, PCR Laboratories, Ramanthapur, Hyderabad–500 013, INDIA.


    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.

    Key words: Mycophenolate mofetil, Mycophenolic acid, Human plasma, Liquid chromatography–tandem mass spectrometry (LC–MS/MS), Method validation, Pharmacokinetics.

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