Development and Validation of Stability Indicating Mass Compatible HPLC Method For Estimation of Deferasirox

Abstract

Deferasirox (DFR) is a new drug treatment for Beta-thalassemia. A simple, specific, linear, accurate, robust, sensitive and precise high-performance liquid chromatography method was developed for Deferasirox. The column used was Phenomenex C18 Column (250 x 4.6mm, 5µm), mobile phase was a ACN:Buffer (60:40 v/v) Buffer consists of 10 mM ammonium acetate, pH of mobile phase was adjusted to 3.5 with 0.1 % formic acid. The flow rate was 1.0 mL/min. Detector wavelength was monitored at 250 nm, and the injection volume was 20 μL and run time was 10 min. The developed method was validated in terms of linearity, range, accuracy, precision, repeatability and specificity, robustness, LOD and LOQ as per ICHQ2(R1). The method as found to be linear in the concentration ranges of (1-25 μg/mL) having LOD 30.01 ng/mL and LOQ 90.96 ng/mL with regression coefficient (R2 ) of 0.9991. The recovery ratio was in the range of 98-102 %. The precision was evaluated by studying intermediate precision and repeatability. The %RSD values for repeatability were 1.8 % and intermediate precision were 0.8 % respectively. Deferasirox (DFR) was subjected to the forced degradation studies showed degradation in acidic condition (15.92 %), alkaline condition (4.8 %), oxidative condition (68.7 %), photolytic condition (1.03 %) while stable in thermal condition. The developed stability indicating mass compatible HPLC method can be used to monitor the quality control of the drug and it can be applied to stability study