title: Isolation and characterization of some potential impurities in ropinirole hydrochloride.
abstract: Three impurities in ropinirole hydrochloride drug substance at levels approximately 0.06-0.15% were detected by reverse-phase high performance liquid chromatography (HPLC). These impurities were isolated from the drug substance. These impurities were analyzed using reverse-phase HPLC. Based on the spectral data (IR, NMR and MS), structures of these impurities were characterized as 4-[2-(propylamino) ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride (impurity-A), 5-[2-(diropylamino) ethyl]-1,4-dihydro-3H-benzoxazin-3-one hydrochloride (impurity-B) and 4-[2-(diropylamino) ethyl]-1H-indol-2,3-dione hydrochloride (impurity-C). Synthesis of these impurities is discussed.
authors.affiliation: Analytical Development Laboratory, BioArc Research Solutions, Alembic Limited, Vadodara 390003, Gujrat, India. bush5@rediffmail.com
authors.forename: B
authors.initials: B
authors.lastname: Sahasrabuddhey
authors.forename: R
authors.initials: R
authors.lastname: Nautiyal
authors.forename: H
authors.initials: H
authors.lastname: Acharya
authors.forename: S
authors.initials: S
authors.lastname: Khyade
authors.forename: P K
authors.initials: PK
authors.lastname: Luthra
authors.forename: P B
authors.initials: PB
authors.lastname: Deshpande
mesh_terms: D000978:Antiparkinson Agents / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004340:Drug Contamination; D007211:Indoles / Q000032:analysis* / Q000737:chemistry; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D015394:Molecular Structure; D013055:Spectrophotometry, Infrared; D017550:Spectroscopy, Fourier Transform Infrared
chemical_list: D000978:Antiparkinson Agents; D007211:Indoles; C046649:ropinirole