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Development and validation of a highly sensitive LC‐MS/MS method for quantitation of dexlansoprazole in human plasma: application to a human pharmacokinetic study
Author(s) -
Hotha Kishore Kumar,
Vijaya Bharathi D.,
Jagadeesh B.,
Ravindranath L. K.,
Jaya Veera K. N.,
Venkateswarulu V.
Publication year - 2012
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.1645
Subject(s) - chromatography , chemistry , electrospray ionization , human plasma , bioequivalence , extraction (chemistry) , selected reaction monitoring , pharmacokinetics , detection limit , electrospray , bioanalysis , high performance liquid chromatography , mass spectrometry , tandem mass spectrometry , pharmacology , medicine
A highly sensitive, specific and simple LC‐MS/MS method was developed for the simultaneous estimation of dexlansoprazole (DEX) with 50 μL of human plasma using omeprazole as an internal standard (IS). The API‐4000 LC‐MS/MS was operated under multiple reaction‐monitoring mode using electrospray ionization. A simple liquid–liquid extraction process was used to extract DEX and IS from human plasma. The total run time was 2.00 min and the elution of DEX and IS occurred at 1.20 min. This was achieved with a mobile phase consisting of 0.2% ammonia–acetonitrile (20:80, v/v) at a flow rate of 0.50 mL/min on an X‐terra RP 18 (50 × 4.6 mm, 5 µm) column. The developed method was validated in human plasma with a lower limit of quantitation of 2 ng/mL for DEX. A linear response function was established for the range of concentrations 2.00–2500.0 ng/mL ( r > 0.998) for DEX. The intra‐ and inter‐day precision values for DEX met the acceptance criteria as per FDA guidelines. DEX was stable in the battery of stability studies, viz. bench‐top, auto‐sampler and freeze–thaw cycles. The developed assay method was applied to an oral bioequivalence study in humans. Copyright © 2011 John Wiley & Sons, Ltd.