Abstract

Deferasirox is used in the treatment of chronic iron overload due to blood transfusions. Many studies have reported the high-performance liquid chromatography, high-performance thin-layer chromatography and ultraviolet spectroscopic methods for the estimation of deferasirox. The current work is intended for the development of a stability indicating method by high-performance thin layer chromatography for the estimation of deferasirox. The chromatographic development was performed on aluminium plates coated with silica gel 60 F₂₅₄ using chloroform:methanol:triethylamine (9:1:0.5 v/v/v) as the mobile phase. Densitometric scanning was achieved at the absorbance maxima 248 nm. Deferasirox was subjected to stress conditions like hydrolysis under different pH conditions, acid, alkali, oxidation, thermal and photolytic stress conditions. A well-separated band was observed with an retardation factor value of 0.44±0.03. The calibration curve plotted in the concentration range 250-1250 ng/band exhibited an excellent linear relationship with the coefficient of determination value of 0.9951. The method was found to comply with all the validation parameters as per the International Council for Harmonisation guidelines Q2(R1). This stability indicating method ensures a short analysis time compared to other reported analytical methods. This validated method can be used by quality control laboratories for monitoring the stability of deferasirox.