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

Shivva Vittal, Ramesh Ganneboina, Buddhadev Layek, Ravi Kumar Trivedi, Kishore Kumar Hotha, D. Vijaya Bharathi, Ramesh Mullangi

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

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 2.5min. 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.

Original languageEnglish (US)
Pages (from-to)390-396
Number of pages7
JournalBiomedical Chromatography
Volume23
Issue number4
DOIs
StatePublished - Apr 27 2009

Keywords

  • Human plasma
  • LC-MS/MS
  • Method validation
  • Omeprazole
  • Pharmacokinetics

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