Removal of potentioally genotoxic impurity from fluroxamine maleate crude drug by molecularly imprinted polymer

Hamid Hashemi-Moghaddam; Mohammad Shakeri

Korean Journal of Chemical Engineering, Vol.31, No.10, 1898-1902, October, 2014

DOI10.1007/s11814-014-0110-7 Export Citation

Removal of potentioally genotoxic impurity from fluroxamine maleate crude drug by molecularly imprinted polymer

Hamid Hashemi-Moghaddam^†, and Mohammad Shakeri

Department of Chemistry, Damghan Branch, Islamic Azad University, Damghan, Iran

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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.

Keywords:Molecularly Imprinted Polymer;Genotoxic Impurities;Fluvoxamine Maleate;Solid Phase Extraction

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[2] Figgitt DP, McClellan KJ, Drugs, 60, 4 (2000)

[3] Stahl SM, Stahl’s essential psychopharmacology: Neuroscientific basis and practical applications, Cambridge University Press (2013)

[4] Wilkinson A, Courtney M, Westlind-Danielsson A, Hallnemo G, Akerman KE, J. Pharmacol. Exp. Ther., 271, 3 (1994)

[5] Nicholson KL, Balster RL, Psychopharmacology, 170, 2 (2003)

[6] Pharmacopoeia B A-290 4 (2007)

[7] Fritz JS, Analytical solid-phase extraction, Wiley-Vch New York (1999)

[8] Hennion MC, J. Chromatogr. A, 856, 1 (1999)

[9] Pichon V, Chapuis-Hugon F, Anal. Chim. Acta, 622, 1 (2008)

[10] Pichon V, J. Chromatogr. A, 1152, 1 (2007)

[11] Mayes A, Whitcombe M, Adv. Drug Deliv. Rev., 57, 12 (2005)

[12] Spivak DA, Adv. Drug Deliv. Rev., 57, 12 (2005)

[13] Mei S, Wu D, Jiang M, Lu B, Lim JM, Zhou YK, Lee YI, Microchem. J., 98, 1 (2011)

[14] Blomgren A, Berggren C, Holmberg A, Larsson F, Sellergren B, Ensing K, J. Chromatogr. A, 975, 1 (2002)

[15] Song S, Shi X, Li R, Lin Z, Wu A, Zhang D, Process Biochem., 43, 11 (2008)

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[21] Chapuis F, Pichon V, Lanza F, Sellergren S, Hennion MC, J. Chromatogr. A, 999, 1 (2003)

[22] Claude B, Morin P, Lafosse M, Belmont AS, Haupt K, Talanta, 75, 2 (2008)

[23] Hu SG, Li L, He XW, J. Chromatogr. A, 1062, 1 (2005)

[24] Baggiani C, Anfossi L, Giovannoli C, Anal. Chim. Acta, 591, 1 (2007)

[25] Mahony J, Nolan K, Smyth M, Mizaikoff B, Anal. Chim. Acta, 534, 1 (2005)