Quantification of tenatoprazole in rat plasma by HPLC: validation and its application to pharmacokinetic studies

Biomed Chromatogr. 2007 Dec;21(12):1240-4. doi: 10.1002/bmc.875.

Abstract

A simple, reliable HPLC method with UV detection (295 nm) in rat plasma was developed and validated for quantification of tenatoprazole, a novel proton pump inhibitor, which is in clinical trials. Following a single-step liquid-liquid extraction, the analyte and internal standard were separated using an isocratic mobile phase on a reverse phase C(18) column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 10%. A linear dynamic range of 20-6000 ng/mL was established. This HPLC method was validated with between-batch and within-batch precision of 2.9-6.3 and 1.4-5.8%, respectively. The between-batch and within-batch accuracy was 95.1-104.1 and 92.4-101.0%, respectively. This validated method is simple and repeatable enough to be used in pharmacokinetic studies.

Publication types

  • Validation Study

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Animals
  • Chromatography, High Pressure Liquid / methods
  • Imidazoles / blood*
  • Imidazoles / pharmacokinetics
  • Imidazoles / standards
  • Male
  • Omeprazole / analogs & derivatives*
  • Omeprazole / blood
  • Omeprazole / pharmacokinetics
  • Omeprazole / standards
  • Proton Pump Inhibitors / blood*
  • Proton Pump Inhibitors / pharmacokinetics
  • Proton Pump Inhibitors / standards
  • Pyridines / blood*
  • Pyridines / pharmacokinetics
  • Pyridines / standards
  • Rats
  • Rats, Wistar
  • Reference Values
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Spectrophotometry, Ultraviolet / methods
  • Time Factors

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Imidazoles
  • Proton Pump Inhibitors
  • Pyridines
  • Omeprazole
  • Tenatoprazole