title: A new HPLC UV validated method for therapeutic monitoring of deferasirox in thalassaemic patients.
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.
authors.affiliation: Clinical Pharmacology, Department of Clinical and Biological Sciences, University of Turin, S. Luigi Gonzaga Hospital, Regione Gonzole 10, 10043 Orbassano (TO), Italy. silvia.defrancia@unito.it
authors.forename: Silvia
authors.initials: S
authors.lastname: De Francia
authors.forename: Davide
authors.initials: D
authors.lastname: Massano
authors.forename: Francesca Maria
authors.initials: FM
authors.lastname: Piccione
authors.forename: Elisa
authors.initials: E
authors.lastname: Pirro
authors.forename: Silvia
authors.initials: S
authors.lastname: Racca
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Carlo
authors.forename: Antonio
authors.initials: A
authors.lastname: Piga
mesh_terms: D001565:Benzoates / Q000097:blood* / Q000627:therapeutic use*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D000077588:Deferasirox; D005260:Female; D005293:Ferritins / Q000097:blood; D006801:Humans; D016014:Linear Models; D008297:Male; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D018709:Statistics, Nonparametric; D013789:Thalassemia / Q000097:blood* / Q000188:drug therapy*; D014230:Triazoles / Q000097:blood* / Q000627:therapeutic use*
chemical_list: D001565:Benzoates; D014230:Triazoles; D005293:Ferritins; D000077588:Deferasirox