ISOLATION AND CHARACTERIZATION OF PROCESS RELATED IMPURITY IN CEFUROXIME ACTIVE PHARMACEUTICAL INGREDIENT
P. Janaki Pathi*1, N. Appala Raju2
The impurity ranging from 0.08%-0.12% by peak area in Cefuroxime active pharmaceutical ingredient was detected by simple isocratic reverse-phase high performance liquid chromatography (HPLC). The impurity was isolated by prep-HPLC and characterized by LC-MS/MS and NMR experimental data. Based on the results obtained from different spectroscopic experiments, the impurity has been characterized as Anti Cefuroximic acid chemically known as [(6R, 7R)-3-[(Acetoxy) methyl]-7-[(2E) -2-furanyl (methoxyimino) acetyl] amino]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid].
Keywords: Cefuroxime, prep-HPLC, impurities, Mass Spectrometry, NMR, identification and characterization.