TITLE:
Low Level Determination of Genotoxic Impurity in Deferasirox Formulation
AUTHORS:
Pravish Kumar Tiwari, Padmakar Sathe, Navin Devadiga
KEYWORDS:
Deferasirox; Genotoxic; 4-Hydrazinobenzoic Acid; HPLC
JOURNAL NAME:
Journal of Analytical Sciences, Methods and Instrumentation,
Vol.3 No.4,
October
22,
2013
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.