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

S. Harikrishna | Zendy; K. Nagabhushana Reddy | Zendy; Y. Suresh | Zendy; Me Ramakrishna | Zendy; M Sarat | Zendy; K. Kishore | Zendy; C. Rambabu | Zendy

Open Access

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

Author(s) -

S. Harikrishna,

K. Nagabhushana Reddy,

Y. Suresh,

Me Ramakrishna,

M Sarat,

K. Kishore,

C. Rambabu

Publication year - 2009

Publication title -

journal of chemistry

Language(s) - English

Resource type - Journals

eISSN - 2090-9063

pISSN - 2090-9071

DOI - 10.1155/2010/616494

Subject(s) - chemistry , chromatography , high performance liquid chromatography , mass spectrometry , drug , benzoic acid , pharmacology , organic chemistry , medicine

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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