Development and Validation of a Rapid and Sensitive LC-MS/MS Method for the Pharmacokinetic Study of Osimertinib in Rats

J AOAC Int. 2017 Nov 1;100(6):1771-1775. doi: 10.5740/jaoacint.16-0362. Epub 2017 May 22.

Abstract

Osimertinib is a new-generation epidermal growth factor inhibitor for the treatment of non-small cell lung cancer. In the present study, a rapid and sensitive LC with tandem MS method was developed and validated for the determination of osimertinib in rat plasma. Chromatographic separation was carried out on a C18 column using acetonitrile and water containing 0.1% formic acid. The assay was validated over a concentration range of 1.0-1000 ng/mL for osimertinib, with a lower LOQ of 1.0 ng/mL. The intra- and interday accuracy values for osimertinib ranged from 92.66 to 101.50% and from 97.08 to 99.15%, respectively, and the intra- and interday precision values for osimertinib ranged from 6.25 to 10.34% and from 3.43 to 10.44%, respectively. The method was successfully applied in a pharmacokinetic study of osimertinib after oral administration of osimertinib (4.5 mg/kg) to rats.

Publication types

  • Validation Study
  • Video-Audio Media

MeSH terms

  • Acrylamides
  • Administration, Oral
  • Aniline Compounds
  • Animals
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / blood
  • Antineoplastic Agents / pharmacokinetics
  • Area Under Curve
  • Chromatography, Liquid / methods*
  • Drug Stability
  • Limit of Detection
  • Male
  • Piperazines / administration & dosage
  • Piperazines / blood*
  • Piperazines / pharmacokinetics*
  • Rats, Sprague-Dawley
  • Sensitivity and Specificity
  • Tandem Mass Spectrometry / methods*

Substances

  • Acrylamides
  • Aniline Compounds
  • Antineoplastic Agents
  • Piperazines
  • osimertinib