Rapid and sensitive LC/MS/MS analysis of the novel tyrosine kinase inhibitor ZD6474 in mouse plasma and tissues

J Pharm Biomed Anal. 2005 Sep 15;39(3-4):705-11. doi: 10.1016/j.jpba.2005.04.024.

Abstract

ZD6474 (N-(4-Bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl)methoxy] quinazolin-4-amine) is a tyrosine kinase inhibitor with anti-angiogenic and anti-tumor activity that is currently undergoing human trials for cancer treatment. Pharmacokinetic studies in animal models are an important component in clinical development of this agent to relate pre-clinical models to patient treatment. A liquid chromatography tandem mass spectrometry method was developed for the determination of ZD6474 levels in mouse plasma and tissues. Plasma (0.05 mL) and tissue homogenates (0.1 mL of 10 mg/mL) were extracted under alkaline conditions with ethyl acetate:pentane (1:1, v/v) after addition of the internal standard (trazodone, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridine-3(2H)-one). Separation was achieved on a C18, 50 mm x 2 mm column with quantitation by internal standard reference and multiple reaction monitoring of the ion transitions m/z 475-->112 (ZD6474) and m/z 372-->176 (trazodone). The calibration curve was linear from a range spanning 20-20,000 ng/mL in plasma and 10-320 ng/mg in tissue homogenates. Mean recoveries from plasma and tissue homogenates were 88 and 90%, respectively. The accuracy in plasma was 88% at the lower limit of quantitation (20 ng/mL with a 50 microL plasma sample) with high precision (R.S.D.%<10%). Assay performance in liver and other tissue homogenates is also reported. The assay was applied to a pharmacokinetic study in mice to determine dosing schedules that would approximate therapeutic ZD6474 levels determined in humans.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / analysis
  • Animals
  • Antineoplastic Agents / pharmacology
  • Calibration
  • Chemistry, Pharmaceutical / methods*
  • Chromatography / methods
  • Chromatography, Liquid / methods*
  • Drug Screening Assays, Antitumor / methods*
  • Enzyme Inhibitors / pharmacology
  • Female
  • Humans
  • Ions
  • Liver / drug effects
  • Liver / metabolism
  • Mass Spectrometry / methods*
  • Mice
  • Mice, Inbred BALB C
  • Models, Chemical
  • Neoplasms / drug therapy*
  • Pentanes / analysis
  • Piperidines / analysis*
  • Piperidines / chemistry
  • Piperidines / pharmacokinetics*
  • Protein-Tyrosine Kinases / antagonists & inhibitors
  • Quinazolines / analysis*
  • Quinazolines / chemistry
  • Quinazolines / pharmacokinetics*
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Time Factors
  • Tissue Distribution
  • Trazodone / analysis

Substances

  • Acetates
  • Antineoplastic Agents
  • Enzyme Inhibitors
  • Ions
  • Pentanes
  • Piperidines
  • Quinazolines
  • pentane
  • ethyl acetate
  • Protein-Tyrosine Kinases
  • Trazodone
  • vandetanib