title: Isolation, structural elucidation and characterization of impurities in Cefdinir.
abstract: Three unknown impurities in Cefdinir bulk drug at levels below 0.2% (ranging from 0.05 to 0.2%) have been detected by high performance liquid chromatography (HPLC). These impurities were isolated from crude sample of Cefdinir using preparative HPLC. Based on the spectral data (NMR, IR and MS) the structures of these impurities were characterized as (6R, 7R)-7-[(z)-2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid-5-oxide (I). (6R, 7R)-7-[(z)-2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-8-oxo-3-vinyl-5-thia-1-azabi-cyclo [4.2.0] oct-3-ene-2-carboxylic acid (II). (6R, 7R)-7-[(z)-2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-8-oxo-3-methyl-5-thia-1-azabicyclo-[4.2.0]oct-2-ene-2-carboxylic acid (III), respectively. The origin and structural elucidation of all impurities have been discussed.
authors.affiliation: Department of Chemical Research, Aurobindo Pharma Research Centre, 313 Bachupally, Quthubullapur Mandal, Hyderabad 500072, India.
authors.forename: K V V Prasada
authors.initials: KV
authors.lastname: Rao
authors.forename: A
authors.initials: A
authors.lastname: Rani
authors.forename: A V Raghava
authors.initials: AV
authors.lastname: Reddy
authors.forename: C H
authors.initials: CH
authors.lastname: Bharathi
authors.forename: Ramesh
authors.initials: R
authors.lastname: Dandala
authors.forename: A
authors.initials: A
authors.lastname: Naidu
mesh_terms: D000900:Anti-Bacterial Agents / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D000077525:Cefdinir; D002511:Cephalosporins / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D015394:Molecular Structure; D017550:Spectroscopy, Fourier Transform Infrared
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D000077525:Cefdinir