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Abstract

Aim: An LC–MS/MS assay for the quantitation of liraglutide, a peptide-based injectable glucagon-like peptide-1 receptor agonist, has been developed as a convenient alternative to the enzyme-linked immunosorbent assay, and used to characterize liraglutide pharmacokinetics in cynomolgus monkeys. Results: Assay calibration curves exhibited a linear dynamic range of 10–5000 ng/ml and correlation coefficient ≥0.98. Following a 30 μg/kg intravenous dose, liraglutide demonstrated low plasma clearance and distribution volume, which led to a terminal half-life of 6.59 h in monkeys. Conclusion: The dynamic range of our LC–MS/MS assay provides sufficient coverage of the average efficacious liraglutide concentrations in human plasma, and can be used for pharmacokinetics/pharmacodynamics studies in animals and potentially in humans.

Keywords:

  • agonist
  • bioanalytical
  • ELISA
  • enzyme-linked immunosorbent assay
  • GLP-1
  • glucagon-like peptide-1
  • LC–MS/MS
  • liquid chromatography tandem mass Spectrometry
  • liraglutide
  • monkey
  • pharmacokinetics
  • plasma
  • receptor
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