Abstract
Three impurities in ropinirole hydrochloride drug substance at levels ∼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-3 H-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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