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

作者:De Francia Silvia*; Massano Davide; Piccione Francesca Maria; Pirro Elisa; Racca Silvia; Di Carlo Francesco; Piga Antonio
来源:Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences, 2012, 893: 127-133.
DOI:10.1016/j.jchromb.2012.02.047

摘要

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 mu l 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 mu g/ml. Limit of quantification was set at 0.15625 while limit of detection at 0.078125 mu g/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.

  • 出版日期2012-4-15