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Abstract: The present study describes the synthesis and preliminary testing of molecularly imprinted polymers (MIPs) as scavenger resins for removal of the genotoxic impurity (GTI) (2RS)-2-[[2-[[[(1E)-5-methoxy-1-[4(trifluoromethyl) phenyl] pentylidene] amino] oxy] ethyl] amino] butanedioic acid from active pharmaceutical ingredients (API). To compare the performance of this polymer, a control polymer or non-imprinted polymer (NIP) was prepared under the same conditions without the use of template molecule. The synthesized polymers were characterized by FT-IR spectroscopy. The results of the selectivity of the molecularly imprinted polymer for absorption GTI impurity through adsorption experiments reviews were compared with the adsorption of impurity by NIP. Various parameters were optimized, such as time, pH, type of eluent for elution of impurity from polymer, concentration of sample and saturation of polymer. The proposed method was applied for removal of this genotoxic impurity from Fluvoxamine maleate tablet
Template and target information: genotoxic impurity, GTI, (2RS)-2-[[2-[[[(1E)-5-methoxy-1-[4(trifluoromethyl)phenyl]pentylidene]amino]oxy]ethyl]amino]butanedioic acid
Author keywords: molecularly imprinted polymer, Genotoxic impurities, Fluvoxamine Maleate, solid phase extraction