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Low-level Determination of 4-Hydrazino BenzoicAcid in Drug Substance by High Performance Liquid Chromatography/Mass Spectrometry
S. Harikrishna
,1 K. Nagabhushana Reddy,1 Y. Suresh,1 M. Ramakrishna,1 M. Sarat,1 K. Kishore,1 and C. Rambabu11Analytical Development, Matrix Laboratories Ltd, Hyderabad 500055, India
Abstract
HPLC/MS single ion monitoring methods have been evaluated for the determination of trace levels of 4- hydrazino benzoic acid (4-HBA) in drug substances. These 4-HBA have been highlighted as potential genotoxins. HPLC/MS was found to be more promising and limits of quantification was 0.52 ppm. For one drug substances excellent recoveries of 104.6% were obtained at the 0.5 ppm level.
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Copyright © 2010 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
