Low Level Determination of Genotoxic Impurity in Deferasirox Formulation

Abstract

4-hydrazinobenzoic acid has been highlighted as one of the potential genotoxic impurities (PGIs). A sensitive HPLC method was developed and validated for the determination of 4-hydrazino benzoic acid in Deferasirox Tablet. HPLC method on Zorbax SB C18 column (250 × 4.6 mm i.d.), 5 μm, with UV Detector was used. The proposed method was cost effective, specific, linear, accurate, rugged and precise. The calibration curves showed good linearity over the concentration range of 0.5 μg/ml to 1.5 μg/ml with respect to the sample. The correlation coefficient was 0.999. Excellent recoveries of 102% were obtained at the level 0.5 μg/ml.