Abstract
Synthesis and characterization of pharmacopeial impurities of quetiapine hemifumarate: An antipsychotic drug
Author(s): K.Suneel Kumar, K.Tatendra Reddy, A.Vamsi Kanth, G.Omprakash, P.K.DubeyEuropean 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.
