Isolation and characterization of some potential impurities in ropinirole hydrochloride |
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Authors: | Sahasrabuddhey B Nautiyal R Acharya H Khyade S Luthra P K Deshpande P B |
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Affiliation: | Analytical Development Laboratory, BioArc Research Solutions, Alembic Limited, Vadodara 390003, Gujrat, India. bush5@rediffmail.com |
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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. |
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Keywords: | LC, liquid chromatography HPLC, high performance liquid chromatography LC–MS, liquid chromatography–mass spectrometry CZE, capillary zone electrophoresis CLC, capillary liquid chromatography GR, guaranteed reagent AR, analytical grade PDA, photo diode array UV, ultra violet FT-IR, Fourier transform infra red ESI, electron spray ionization DP, declustring potential EP, entrance potential NMR, nuclear magnetic resonance APT, attached proton test RF, retention factor DMSO, dimethyl sulfoxide D2O, deuterium oxide |
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