Low Level Determination of Genotoxic Impurity in Deferasirox Formulation


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.

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P. Tiwari, P. Sathe and N. Devadiga, "Low Level Determination of Genotoxic Impurity in Deferasirox Formulation," Journal of Analytical Sciences, Methods and Instrumentation, Vol. 3 No. 4, 2013, pp. 179-183. doi: 10.4236/jasmi.2013.34023.

Conflicts of Interest

The authors declare no conflicts of interest.


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