High-performance liquid chromatography method for the quantification of pantoprazole in human plasma

J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Aug 5;822(1-2):326-9. doi: 10.1016/j.jchromb.2005.06.011.

Abstract

A sensitive and selective HPLC method with UV detection (290 nm) was developed and validated for quantitation of pantoprazole, proton-pump inhibitor, in human plasma. Following a single-step liquid-liquid extraction with methyl tert-butyl ether/diethyl ether (70/30, v/v), the analyte and internal standard (zonisamide) were separated using an isocratic mobile phase of 10mM phosphate buffer (pH 6.0)/acetonitrile (61/39, v/v) on reverse phase Waters symmetry C18 column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 4%. A linear range of 20-5000 ng/mL was established. This HPLC method was validated with between-batch and within-batch precision of 1.3-3.2% and 0.7-3.3%, respectively. The between-batch and within-batch bias was -0.5 to 8.2 % and -2.5 to 12.1%, respectively. This validated method is sensitive and repeatable enough to be used in pharmacokinetic studies.

Publication types

  • Validation Study

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Benzimidazoles / blood*
  • Chromatography, High Pressure Liquid / methods*
  • Humans
  • Omeprazole / analogs & derivatives*
  • Omeprazole / blood
  • Pantoprazole
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Sulfoxides / blood*
  • Ultraviolet Rays

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Benzimidazoles
  • Sulfoxides
  • Pantoprazole
  • Omeprazole