A new HPLC UV validated method for therapeutic monitoring of deferasirox in thalassaemic patients

J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Apr 15:893-894:127-33. doi: 10.1016/j.jchromb.2012.02.047. Epub 2012 Mar 6.

Abstract

We describe a new high performance liquid chromatography coupled with ultraviolet detection method for the quantification of plasma concentration of oral iron chelating agent deferasirox. A simple protein precipitation extraction procedure was applied on 500 μl of plasma aliquots. Chromatographic separation was achieved on a C18 reverse phase column and eluate was monitored at 295 nm, with 8 min of analytical run. This method has been validated following Food and Drug Administration procedures: mean intra and inter day variability was 4.64 and 10.55%; mean accuracy was 6.27%; mean extraction recovery 91.66%. Calibration curves ranged from 0.078125 to 40 μg/ml. Limit of quantification was set at 0.15625 while limit of detection at 0.078125 μg/ml. We applied methodology developed on plasma samples of thalassaemic patients treated with deferasirox, finding correlation between deferasirox plasma concentrations and serum ferritin levels. This methodology allowed a specific, sensitive and reliable determination of deferasirox, that could be useful to perform its therapeutic monitoring and pharmacokinetic studies in patients plasma.

MeSH terms

  • Benzoates / blood*
  • Benzoates / therapeutic use*
  • Chromatography, High Pressure Liquid / methods*
  • Deferasirox
  • Female
  • Ferritins / blood
  • Humans
  • Linear Models
  • Male
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Statistics, Nonparametric
  • Thalassemia / blood*
  • Thalassemia / drug therapy*
  • Triazoles / blood*
  • Triazoles / therapeutic use*

Substances

  • Benzoates
  • Triazoles
  • Ferritins
  • Deferasirox