Isolation and characterization of some potential impurities in ropinirole hydrochloride.
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.
Sahasrabuddhey
B
B
Analytical Development Laboratory, BioArc Research Solutions, Alembic Limited, Vadodara 390003, Gujrat, India. bush5@rediffmail.com
Nautiyal
R
R
Acharya
H
H
Khyade
S
S
Luthra
P K
PK
Deshpande
P B
PB
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
D000978:Antiparkinson Agents; D007211:Indoles; C046649:ropinirole