E-Journal of Chemistry (Jan 2010)

Low-level Determination of 4-Hydrazino BenzoicAcid in Drug Substance by High Performance Liquid Chromatography/Mass Spectrometry

  • S. Harikrishna,
  • K. Nagabhushana Reddy,
  • Y. Suresh,
  • M. Ramakrishna,
  • M. Sarat,
  • K. Kishore,
  • C. Rambabu

DOI
https://doi.org/10.1155/2010/616494
Journal volume & issue
Vol. 7, no. 2
pp. 403 – 408

Abstract

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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.