Sensitive quantification of omeprazole and its metabolites in human plasma by liquid chromatography-mass spectrometry

J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Feb 2;831(1-2):85-90. doi: 10.1016/j.jchromb.2005.11.036. Epub 2005 Dec 9.

Abstract

A sensitive method was developed for the simultaneous determination of omeprazole and its major metabolites 5-hydroxyomeprazole and omeprazole sulfone in human plasma by HPLC-electrospray mass spectrometry. Following liquid-liquid extraction HPLC separation was achieved on a ProntoSil AQ, C18 column using a gradient with 10 mM ammonium acetate in water (pH 7.25) and acetonitrile. The mass spectrometer was operated in the selected ion monitoring mode using the respective MH(+) ions, m/z 346 for omeprazole, m/z 362 for 5-hydroxy-omeprazole and omeprazol-sulfone and m/z 300 for the internal standard (2-{[(3,5-dimethylpyridine-2-yl)methyl]thio}-1H-benzimidazole-5-yl)methanol. The limit of quantification (LOQ) achieved with this method was 5 ng/ml for 5-hydroxyomeprazole and 10 ng/ml for omeprazole and omeprazole-sulfone using 0.25 ml of plasma. Intra- and inter-assay variability was below 11% over the whole concentration range from 5 to 250 ng/ml for 5-hydroxyomeprazol and from 10 to 750 ng/ml for omeprazole and omeprazole-sulfone. The method was successfully applied to the determination of pharmacokinetic parameters of esomeprazole and the two major metabolites after a single dose and under steady state conditions.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Chromatography, High Pressure Liquid / methods*
  • Esomeprazole
  • Gastroesophageal Reflux / blood
  • Humans
  • Omeprazole / blood*
  • Omeprazole / metabolism
  • Omeprazole / pharmacokinetics
  • Sensitivity and Specificity
  • Spectrometry, Mass, Electrospray Ionization / methods

Substances

  • Omeprazole
  • Esomeprazole