Application of Aqueous Gel Permeation Chromatography with In-Line Multi-Angle Laser Light Scattering and Differential Viscometry Detectors for the Characterization of Natural Product Carbohydrate Pharmaceuticals

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Abstract
Natural product complex carbohydrate polymers are currently being developed as prophylactic and/or therapeutic drugs. These water-soluble carbohydrate pharmaceuticals, which are primarily β-1, 3-D-glucan polymers, belong to the class of drugs known as biological response modifiers (BRMs). A major obstacle to the development, understanding and clinical utilization of carbohydrate BRMs has been the difficulty involved in accurately characterizing high molecular weight (MW) carbohydrate polymers. Recent advances in aqueous gel permeation chromatography (GPC), differential viscometry (DV) and multi- significance of these observations are readily apparent. As stated above, the characterization and quality control of natural product carbohydrate BRMs has, in the past, relied heavily on bioassays and conventional GPC. The data presented demonstrate the applicability of high performance GPC with multiple detectors in the analysis of complex carbohydrate BRMs. This technology when combined with other analytical techniques such as high-field 13C and 1H-NMR, elemental analysis, helix coil transition analysis and exhaustive methylation/gas chromatography/mass spectrometry (12) provide a much more complete description of this novel class of pharmaceuticals.