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Published on: April 23, 2019
Identification and characterization of new impurities in rivastigmine
M Srinivasa Rao1, Sumathi V Rao, D V N Srinivasa Rao
1APL Research Centre, Hyderabad, India.
Abstract:
Rivastigmine is a drug against Alzheimer's disease, and is a non-pharmacopoeial compound. During the preparation of rivastigmine in our laboratory, two impurities were detected and identified with a simple and sensitive reversed-phase liquid chromatography coupled with electrospray-mass spectrometry. The same impurities were also observed in commercial batches. These impurities were isolated by preparative HPLC and co-injected with rivastigmine sample to confirm the retention times in HPLC. These impurities were characterized as N,N-dimethyl-3-[1-dimethylaminoethyl]phenylcarboxylate (dimethyl-rivastigmine) and N,N-diethyl-3-[1-dimethylaminoethyl]phenylcarboxamide (diethyl-rivastigmine). Structural elucidation of these impurities by spectral data (1H NMR, 13C NMR and MS) is discussed.
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