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Synthesis and characterization of pregabalin lactose conjugate degradation products
Michael J Lovdahl1, Timothy R Hurley, Brian Tobias
1Analytical Development Department, Pfizer Global Research and Development, 2800 Plymouth Road, Ann Arbor, MI 48105, USA. michael.lovdahl@pfizer.com
Journal of Pharmaceutical and Biomedical Analysis
|June 1, 2002
Abstract:
Seven degradation products observed in formulated pregabalin have been characterized. These compounds result from Maillard reactions and Amadori rearrangements. Heating pregabalin in the presence of lactose formed significant quantities of these degradation products. The seven compounds corresponding to the observed degradation products were isolated by preparative liquid chromatography. The synthesis, isolation, and spectral characterization of the degradation products are detailed.