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Highly sensitive method for the determination of omeprazole in human plasma by liquid chromatography–electrospray ionization tandem mass spectrometry: application to a clinical pharmacokinetic study
Author(s) -
Vittal Shivva,
Ganneboina Ramesh,
Layek Buddhadev,
Trivedi Ravi Kumar,
Hotha Kishore Kumar,
Bharathi D. Vijaya,
Mullangi Ramesh
Publication year - 2009
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.1129
Subject(s) - chemistry , chromatography , electrospray ionization , tandem mass spectrometry , liquid chromatography–mass spectrometry , pharmacokinetics , mass spectrometry , omeprazole , electrospray , selected reaction monitoring , direct electron ionization liquid chromatography–mass spectrometry interface , ionization , chemical ionization , ion , pharmacology , medicine , organic chemistry
Abstract A highly sensitive, rapid assay method has been developed and validated for the estimation of omeprazole (OPZ) in human plasma with liquid chromatography coupled to tandem mass spectrometry with electrospray ionization in the positive‐ion mode. The assay procedure involves alkalinization of plasma followed by simple liquid–liquid extraction of OPZ and lansoprazole (internal standard, IS) from human plasma with acetonitrile. Chromatographic separation was achieved with 0.01 m ammonium acetate:acetonitrile (40:60, v/v) at a flow rate of 0.25 mL/min on an Inertsil ODS 3 column with a total run time 2.5 min. The MS/MS ion transitions monitored were 346.1 → 198.1 for OPZ and 370.1 → 252.1 for IS. Method validation and clinical sample analysis were performed as per FDA guidelines and the results met the acceptance criteria. The lower limit of quantitation achieved was 0.05 ng/mL and the linearity was observed from 0.05 to 10.0 ng/mL. The intra‐day and inter‐day precisions were in the ranges 2.09–8.56 and 5.29–8.19%, respectively. This novel method has been applied to a pharmacokinetic study of OPZ in humans. Copyright © 2008 John Wiley & Sons, Ltd.