Quantitative Method For The Determination Of Phenyl Hydrazine, A Potential Genotoxic Impurity Of Ondansetron Hydrochloride Using Tandem Mass Spectrometry

[摘要] To estimate the level of Phenylhydrazine, a potential genotoxic impurity in Ondansetron Hydrochloride API, a new simple, sensitive and accurate method was developed using Liquid Chromatographic Mass Spectrometry (LC-MS/MS). The chromatographic separation was achieved on Inert Sustain Swift C18, 5µ (150 x 4.6) mm column with gradient programme and elution was monitored by mass spectrometer in Multiple Reaction Monitoring mode using electrospray ionization. The LOD and LOQ values found to be 5 ppm and 15 ppm for the impurity with respect to the test concentration 2 mg/ml. The method was linear (r2>0.99), precise (RSD<2%), accurate and well within acceptable ICH limits.

[学科分类] 药学

[关键词] Potential genotoxic impurities;Ondansetron Hydrochloride;LC-MS/MS;Multiple Reaction Monitoring (MRM);Threshold of Toxicological Concern (TTC)