Determination of lansoprazole in human plasma by rapid resolution liquid chromatography-electrospray tandem mass spectrometry: application to a bioequivalence study on Chinese volunteers

J Pharm Biomed Anal. 2008 Dec 15;48(5):1485-9. doi: 10.1016/j.jpba.2008.09.046. Epub 2008 Oct 8.

Abstract

A simple, sensitive and rapid LC/MS/MS method was developed for the quantification of lansoprazole in human plasma. After a simple sample preparation procedure by one-step protein precipitation with acetonitrile, lansoprazole and the internal standard bicalutamide were chromatographed on a Zorbax SB-C(18) (3.0 mm x 150 mm, 3.5 microm, Agilent) column with the mobile phase consisted of methanol-water (70:30, v/v, containing 5 mM ammonium formate, pH was adjusted to 7.85 by 1% ammonia solution). Detection was performed on a triple quadrupole tandem mass spectrometry by multiple reaction monitoring (MRM) mode via negative eletrospray ionization source (ESI(-)). The lower limit of quantification was 5.5 ng/mL, and the assay exhibited a linear range of 5.5-2200.0 ng/mL. The validated method was successfully applied to investigate the bioequivalence between two kinds of preparation (test vs. reference product) in twenty-eight healthy male Chinese volunteers.

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / blood*
  • 2-Pyridinylmethylsulfinylbenzimidazoles / chemistry
  • 2-Pyridinylmethylsulfinylbenzimidazoles / pharmacokinetics*
  • Area Under Curve
  • Asian People
  • Calibration
  • Chromatography, Liquid / methods
  • Drug Stability
  • Freezing
  • Half-Life
  • Humans
  • Lansoprazole
  • Molecular Structure
  • Proton Pump Inhibitors
  • Proton Pumps / blood*
  • Proton Pumps / chemistry
  • Proton Pumps / pharmacokinetics*
  • Reference Standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Spectrometry, Mass, Electrospray Ionization / methods*
  • Tandem Mass Spectrometry / methods*
  • Therapeutic Equivalency
  • Time Factors

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Proton Pump Inhibitors
  • Proton Pumps
  • Lansoprazole