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Spectral characterization of rupatadine fumarate and its potential impurities

Ramadas Chavakula, M.Narayana Rao, M.Vijaya Raju, R.V.Nageswara Rao, Ch.Srinivasa Rao

During the process development of rupatadine fumarate (1). Two impurities (2,3) with respect to rupatadine fumarate were detected by in-house method of simple reverse phase high-performance liquid chromatograpjy (HPLC). Three (1-3) have been prepared by the known synthetic method. To the best of our knowledge, compounds (1-3) stracture elucidation had not been reported until now. The 1H and 13C NMR data of impurities (2,3) and rupatadine fumarate (1) were reported in this paper for the first time. Based on the spectral data, the structure of these compounds 1-3 were characterized as 8-Chloro-6, 11-dihydro-11-[1-[(5-methyl-3- pyridinyl)methyl]-4-piperidinylidene]-5Hbenzo[5, 6] cyclohepta [1, 2-b] pyridine fumarate (1), 8-Chloro-11-(4-piperidinylidene)-6,11-dihydro-5Hbenzo[ 5,6]cyclohepta[1,2-b]pyridine (2), 3-(Chloromethyl)-5-methyl pyridine (3). The HPLC analysis and characterization of these drug and impurities were discussed.