Isolation, identification and characterization of degradant impurities in Tolterodine tartrate formulation
作者： Lakkireddy Prakash , M. Himaja , B. Venkata Subbaiah , R. Vasudev , C. Srinivasulu
DOI: 10.1016/J.JPBA.2013.12.007
关键词:
摘要: During the stability study of Tolterodine tartrate drug product, two unknown impurities (Impurities I and II) were detected by ultra performance liquid chromatography (UPLC). Both isolated preparative subjected to mass NMR spectral studies. Based on data, Impurities II characterized as N-(3-(2-hydroxy-5-methylphenyl)-3-phenylpropyl)-N,N-diisopropyl hydroxyl ammonium trifluoro acetate 3-(2-hydroxy-5-methylphenyl)-N-isopropyl-3-phenylpropane-1-amine oxide respectively.
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