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Synthesis and characterization of pharmacopeial impurities of quetiapine hemifumarate: An antipsychotic drug

K.Suneel Kumar, K.Tatendra Reddy, A.Vamsi Kanth, G.Omprakash, P.K.Dubey

European Pharmacopeia 7.0 disclosed ten potential impurities inQuetiapine hemifumarate (1). The acceptable range of these impurities in Quetiapine hemifumarate is from0.05 – 0.15% by reverse-phase HPLC. These impurities were synthesized and analysed by European Pharmacopeial HPLC method and found that these impurities are correlating with the specified retention times.Along with pharmacopeial impurities, Quetiapine S-Oxide impurity is also synthesized. Structural elucidation of all these impurities by spectral data (1H NMR,MS and IR), synthesis and formation of these impurities are discussed in detail.