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    Simultaneous determination of pentoxifylline, metabolites M1 (lisofylline), M4 and M5, and caffeine in plasma and dried blood spots for pharmacokinetic studies in preterm infants and neonates

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    Authors
    Page-Sharp, Madhu
    Strunk, T.
    Salman, S.
    Hibbert, J.
    Patole, S.
    Manning, L.
    Batty, Kevin
    Date
    2017
    Type
    Journal Article
    
    Metadata
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    Citation
    Page-Sharp, M. and Strunk, T. and Salman, S. and Hibbert, J. and Patole, S. and Manning, L. and Batty, K. 2017. Simultaneous determination of pentoxifylline, metabolites M1 (lisofylline), M4 and M5, and caffeine in plasma and dried blood spots for pharmacokinetic studies in preterm infants and neonates. Journal of Pharmaceutical and Biomedical Analysis. 146: pp. 302-313.
    Source Title
    Journal of Pharmaceutical and Biomedical Analysis
    DOI
    10.1016/j.jpba.2017.08.030
    ISSN
    0731-7085
    School
    School of Pharmacy and Biomedical Sciences
    URI
    http://hdl.handle.net/20.500.11937/63456
    Collection
    • Curtin Research Publications
    Abstract

    © 2017 Elsevier B.V. Advances in bioanalytical methods are facilitating micro-volume and dried blood spot (DBS) analysis of drugs in biological matrices for pharmacokinetic studies in children and neonates. We sought to develop a UPLC–MS/MS assay for simultaneous measurement of caffeine, pentoxifylline (PTX) and three metabolites of PTX in both plasma and DBS. Caffeine, PTX, the metabolites M1 (lisofylline), M4 and M5, and the internal standards (caffeine-d 9 and PTX-d 6 ) were separated using a Waters Aquity T3 UPLC C 18 column and gradient mobile phase (water-methanol-formic acid). Retention times for caffeine, M5, M4, PTX and M1 were 1.6, 1.7, 1.9, 2.0 and 2.1 min, respectively, with a run time of 5 min. The precision (=10%) and accuracy (=15%) across the concentration range 0.1–50 mg/L for caffeine, PTX and the three metabolites in plasma and DBS were within accepted limits, as were the limits of quantification (100 µg/L for caffeine and 10 µg/L for PTX, M1, M4 and M5). Caffeine, PTX and the metabolites were stable in DBS for > 34 days at room and refrigerated temperatures. Plasma and DBS samples were obtained from 24 preterm infants recruited into a clinical pharmacokinetic study of PTX. Paired analysis indicated that DBS concentrations were 9% lower than concurrent plasma concentrations for caffeine, 7% lower for PTX (consistent with the blood:plasma ratio) and 13% lower for M1 (lisofylline). The validated UPLC–MS/MS method is suitable for micro-volume plasma and DBS analysis of caffeine, PTX and its metabolites for pharmacokinetic studies in paediatric patients.

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