title: Determination of caprolactam and residual vinyl caprolactam monomer in soluplus by mixed mode gel permeation chromatography.
abstract: Soluplus, a graft copolymer of polyethylene glycol, vinyl caprolactam and vinyl acetate, is designed to solubilize poorly soluble active pharmaceutical ingredients. A straightforward aqueous gel permeation chromatography method that exploits both size exclusion and adsorption modes of separation was used to separate and quantify the related residual vinyl caprolactam monomer and caprolactam impurity present in Soluplus. This methodology offers a single step analysis of caprolactam and the residual vinyl caprolacatam monomer, yielding similar results to reversed-phase chromatography measurements, which are time-consuming and may involve multi-step sample preparation. The results of this study demonstrate that gel permeation chromatography provides a viable option to traditional reversed-phase chromatography in the quantitative analysis of residual caprolactam and vinyl caprolactam monomers and can be extended to other monomer-polymeric systems.
authors.affiliation: Analytical Development, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., Ridgefield, CT 06877.
authors.forename: Ashish
authors.initials: A
authors.lastname: Soman
authors.forename: Madhuri
authors.initials: M
authors.lastname: Jerfy
mesh_terms: D002209:Caprolactam / Q000302:isolation & purification*; D002850:Chromatography, Gel; D002851:Chromatography, High Pressure Liquid; D057230:Limit of Detection; D011092:Polyethylene Glycols / Q000032:analysis*; D011145:Polyvinyls / Q000032:analysis*; D059629:Signal-To-Noise Ratio; D012996:Solutions; D012997:Solvents / Q000032:analysis
chemical_list: D011145:Polyvinyls; D012996:Solutions; D012997:Solvents; C572167:polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; D011092:Polyethylene Glycols; D002209:Caprolactam