Development and validation of a sensitive LC-MS/MS assay of GT-14, a novel Gαi2 inhibitor, in rat plasma, and its application in pharmacokinetic study

J Pharm Biomed Anal. 2024 Aug 1:245:116183. doi: 10.1016/j.jpba.2024.116183. Epub 2024 May 3.

Abstract

A sensitive and selective LC-MS/MS method was developed and validated for the quantitation of a novel Gαi2 inhibitor, GT-14, in rat plasma using a SCIEX 6500+ triple QUAD LC-MS system equipped with an ExionLC UHPLC unit. GT-14 (m/z 265.2 → 134.1) and griseofulvin (Internal Standard, IS) (m/z 353.1 → 285.1) were detected in a positive mode by electrospray ionization (ESI) using multiple reaction monitoring (MRM). The assay was linear in the concentration range of 0.78-1000 ng/mL in rat plasma. Both accuracy and precision values were within the acceptance criteria of ±15 %, as established by FDA guidance. The matrix effect was negligible from plasma, with signal percentages of 98.5-106.9 %. The mean recovery was 104.5 %, indicating complete extraction of GT-14 from plasma. GT-14 was found to be stable under different experimental conditions. The validated method was successfully applied to evaluate plasma protein binding and in vivo pharmacokinetics of GT-14 in rats.

Keywords: Gαi2 inhibitor; LC-MS/MS; Pharmacokinetics; Plasma Protein Binding; Validation.

Publication types

  • Validation Study

MeSH terms

  • Animals
  • Chromatography, High Pressure Liquid / methods
  • Chromatography, Liquid / methods
  • Griseofulvin / blood
  • Griseofulvin / pharmacokinetics
  • Liquid Chromatography-Mass Spectrometry
  • Male
  • Protein Binding
  • Rats
  • Rats, Sprague-Dawley*
  • Reproducibility of Results
  • Spectrometry, Mass, Electrospray Ionization / methods
  • Tandem Mass Spectrometry* / methods