A Validated Quantification Method for Brexpiprazole in Dog Plasma

J Chromatogr Sci. 2018 Sep 1;56(8):702-708. doi: 10.1093/chromsci/bmy045.

Abstract

A sensitive, efficient and stable bioanalytical method has been developed and validated for determination of brexpiprazole in dog plasma with UPLC-MS-MS for the first time. Brexpiprazole and internal standard were extracted from plasma samples by liquid-liquid extraction and separated on an Acquity UPLC BEH C18 column. A gradient elution program was developed employing methanol and 10 mM ammonium acetate aqueous solution as mobile phases. The method was validated for parameters of selectivity, LLOQ, linearity, accuracy, precision, matrix effects and stability in accordance with the regulatory guidance on bioanalytical method validation. The validated method was applied in evaluating the pharmacokinetic profiles of brexpiprazole in beagle dogs after a single-dose oral administration of a 4 mg tablet.

Publication types

  • Validation Study

MeSH terms

  • Administration, Oral
  • Animals
  • Chromatography, High Pressure Liquid / methods
  • Dogs / blood*
  • Dopamine Agonists / administration & dosage
  • Dopamine Agonists / blood*
  • Limit of Detection
  • Quinolones / administration & dosage
  • Quinolones / blood*
  • Reproducibility of Results
  • Tandem Mass Spectrometry / methods
  • Thiophenes / administration & dosage
  • Thiophenes / blood*

Substances

  • Dopamine Agonists
  • Quinolones
  • Thiophenes
  • brexpiprazole