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Validated LC-MS/MS method for quantitation of total and free mycophenolic acid concentration and its application to a pharmacokinetic study in pediatric renal transplant recipients.

Authors
  • Liu, Yan1, 2
  • Liu, Longshan3
  • Li, Jingjie4
  • Fu, Qian3
  • Zhang, Huanxi3
  • Wu, Chenglin3
  • Li, Jun3
  • Zhong, Guoping5
  • Zheng, Yifan1
  • Chen, Xiao1
  • Wang, Changxi3, 6
  • Chen, Pan1
  • 1 Department of Pharmacy, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. , (China)
  • 2 Department of Pharmacy, the Third Affiliated Hospital of Nanchang University, Nanchang, China. , (China)
  • 3 Organ Transplant Center, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. , (China)
  • 4 Reproductive medicine center, the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. , (China)
  • 5 Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China. , (China)
  • 6 Guangdong Provincial Key Laboratory on Organ Donation and Transplant Immunology, Guangzhou, China. , (China)
Type
Published Article
Journal
Biomedical Chromatography
Publisher
Wiley (John Wiley & Sons)
Publication Date
Feb 01, 2021
Volume
35
Issue
2
Identifiers
DOI: 10.1002/bmc.4989
PMID: 32959916
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

A simple and sensitive LC-MS/MS method was established to quantify total and free mycophenolic acid (MPA) plasma concentrations during immunosuppressive medication for pediatric renal transplantation. The chromatographic separation was performed with the Hypersil GOLD C18 column, using a mobile phase consisting of 0.1% formic acid in water and acetonitrile (60:40, v/v) at an isocratic flow rate of 0.4 ml/min. An Agilent 6420 triple quadrupole mass spectrometer was operated via a positive electrospray ionization interface using the transitions m/z 321.14 → 206.9 for MPA and m/z 324.15 → 209.9 for MPA-d3 (internal standard). The linearity was 0.1-50 μg/ml for total MPA and 0.0025-0.5 μg/ml for free MPA. The within-run and between-run precisions were all <5% and accuracy was within 96.23-107.63%. The validated method was successfully aspplied to a pharmacokinetic study in 28 pediatric renal recipients. The mean free fraction of MPA in our patients was 0.89% (ranging from 0.62 to 1.25%) and albumin level played a major role in the variability of free fraction of MPA, thus, in pediatric patients with hypoproteinemia, close free drug monitoring and dose adjustments should be considered to prevent toxicity. © 2020 John Wiley & Sons, Ltd.

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