Liquid chromatographic analysis for the determination of deferasirox in pharmaceutical formulations and spiked plasma samples using dansyl chloride reagent

Abstract

In the current study, a new sensitive and precise method based on HPLC and derivatization withdansyl chloride was developed for quantification of deferasirox (DEF) in pharmaceutical dosage forms andspiked plasma samples. Separation procedure in the chromatographic system was performed using a mobilephase consisting of the mixture of methanol and acetic acid solution (0.5 M, pH adjusted to 7.0 with NaOH) witha ratio of 70:30 v/v at flow rate of 1.0 mL per minute under isocratic elution on a C18 column (150 mm × 4.6mm, 5 μm I.D.). The excitation wavelength was selected as 340 nm and emission wavelength was selected as480 nm for the measurement of the analyte signal. The retention time for DEF is approximately 3.5 min. ICHGuidelines were taken into account for method validation. For the deferasirox concentration range of 20–2000ng/mL, the proposed analytical method exhibited a linear relationship between the drug concentration andmeasured fluorescence with a correlation coefficient of 0.9994.The currently developed method can beimplemented efficiently for the quantification of DEF in pharmaceutical dosage forms and spiked plasmasamples.