Development and validation of a liquid chromatography-tandem mass spectrometry assay for the simultaneous quantitation of prednisolone and dipyridamole in human plasma and its application in a pharmacokinetic study

J Pharm Biomed Anal. 2009 Jul 12;49(5):1241-9. doi: 10.1016/j.jpba.2009.02.017. Epub 2009 Feb 25.

Abstract

We have developed and validated an accurate, sensitive, and robust LC-MS/MS method that determines the concentration of CRx-102 (the combination of prednisolone and dipyridamole) in human plasma. In this method, prednisolone, dipyridamole, and the combined internal standards (IS) prednisolone-d(6) (IS for prednisolone) and dipyridamole-d(20) (IS for dipyridamole) were extracted from 100 microL human EDTA plasma using methylbutyl ether. Calibration curves were linear over a concentration range of 0.4-200 ng/mL for prednisolone and 5-3000 ng/mL for dipyridamole. The analytes were quantitatively determined using tandem mass spectrometry operated in positive electrospray ionization in a multiple reaction monitoring (MRM) mode. This validated method has been used successfully in clinical pharmacokinetic studies of CRx-102 in healthy volunteers.

MeSH terms

  • Area Under Curve
  • Calibration
  • Chromatography, Liquid / methods*
  • Dipyridamole / blood*
  • Dipyridamole / chemistry
  • Dipyridamole / pharmacokinetics
  • Drug Combinations
  • Drug Stability
  • Freezing
  • Half-Life
  • Humans
  • Metabolic Clearance Rate
  • Molecular Structure
  • Prednisolone / blood*
  • Prednisolone / chemistry
  • Prednisolone / pharmacokinetics
  • Quality Control
  • Reference Standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Spectrometry, Mass, Electrospray Ionization / methods
  • Tandem Mass Spectrometry / methods*
  • Temperature
  • Time Factors

Substances

  • Drug Combinations
  • Dipyridamole
  • Prednisolone