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Determination of mycophenolic acid in human plasma by ultra performance liquid chromatography-tandem mass spectrometry and its pharmacokinetic application in kidney transplant patients.

Biomed Chromatogr. 2019 Aug 16;:e4681

Authors: Reséndiz-Galván JE, Romano-Aguilar M, Medellín-Garibay SE, Milán-Segovia RDC, Chevaile-Ramos A, Romano-Moreno S

Abstract
OBJECTIVE: To implement and validate an analytical method by ultra performance liquid chromatography-tandem mass spectrometry (UPLC MS/MS) to quantify MPA in kidney transplant patients.
METHODS: The MPA quantification was performed in an ACQUITY UPLC H Class coupled to XEVO® TQD detector and was extracted from plasma samples by protein precipitation. The chromatographic separation was achieved through an ACQUITY HSS C18 SB column with 0.1% formic acid and acetonitrile (60:40 v/v) as mobile phase. The pharmacokinetic parameters were calculated by non-compartmental analysis of MPA plasma concentrations from 10 kidney transplant patients.
RESULTS: The linear range for MPA quantification was 0.2-30 mg/L with a limit of detection of 0.07 mg/L; the mean extraction recovery was 99.99%. The mean intra- and inter-day variability were 2.98 and 3.4% with a percentage of deviation of 8.4 and 6.6%, respectively. Mean maximal concentration of 10 mg/L at 1.5 h, area under the concentration-time curve of 36.8 mg·h/L, elimination half-life of 3.9 h, clearance of 0.32 L/h/Kg and volume of distribution of 1.65 L/Kg were obtained from MPA pharmacokinetics profiles.
CONCLUSION: A simple, fast and reliable UPLC-MS/MS method to quantify MPA in plasma was validated and has been applied for pharmacokinetic analysis in kidney transplant patients.

PMID: 31419321 [PubMed – as supplied by publisher]

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