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S. Glowienke, W. Frieauff, T. Allmendinger, H. Martus, W. Suter and L. Mueller, “Structure-Activity Considerations and in Vitro Approaches to Assess the Genotoxicity of 19 Methane-, Benzen and Toluenesulfonic Acid Esters,” Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol. 581, No. 1-2, 2005, pp. 23-24. http://dx.doi.org/10.1016/j.mrgentox.2004.10.004
has been cited by the following article:
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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.