Determination of pantoprazole in human plasma by LC-MS-MS using lansoprazole as internal standard

Arzneimittelforschung. 2004;54(6):314-9. doi: 10.1055/s-0031-1296977.

Abstract

An analytical method based on liquid chromatography with positive ion electrospray ionization (ESI) coupled to tandem mass spectrometry detection was developed for the determination of pantoprazole (CAS 102625-70-7) in human plasma using lansoprazole (CAS 103577-45-3) as the internal standard. The analyte and internal standard were extracted from the plasma samples by liquid/liquid extraction using diethyl-ether/dichloromethane (70:30; v/v) and chromatographed on a C8 analytical column. The mobile phase consisted of acetonitrile/ water/methanol (57:25:18; v/v/v) + 10 mmol/l acetic acid + 20 mmol/l ammonium acetate. The method has a chromatographic total run time of 4.5 min and was linear within the range 5.0-5,000 ng/ mL. Detection was performed on a triple quadrupole tandem mass spectrometer by Multiple Reaction Monitoring (MRM). The intra- and inter-run precisions calculated from quality control (QC) samples were 4.2 % and 3.2 %, respectively. The accuracies as determined from QC samples were -5.0 % (intra-run) and 2.0 % (inter-run). The method herein described was employed in a bioequivalence study of two tablet formulations of pantoprazole.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents / blood*
  • Benzimidazoles / blood*
  • Calibration
  • Chemistry, Pharmaceutical
  • Chromatography, Liquid
  • Humans
  • Indicators and Reagents
  • Lansoprazole
  • Mass Spectrometry
  • Omeprazole / analogs & derivatives*
  • Omeprazole / chemistry*
  • Pantoprazole
  • Quality Control
  • Reference Standards
  • Reproducibility of Results
  • Sulfoxides / blood*
  • Therapeutic Equivalency

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Benzimidazoles
  • Indicators and Reagents
  • Sulfoxides
  • Lansoprazole
  • Pantoprazole
  • Omeprazole