title: Size exclusion chromatography with Corona charged aerosol detector for the analysis of polyethylene glycol polymer.
abstract: A technique of using size exclusion chromatography (SEC) with the Corona charged aerosol detector (CAD) was developed and evaluated in comparison with refractive index (RI) and evaporative light scattering detection (ELSD) for fast screening of polyethylene glycol (PEG), a polymer used in preparing pegylated pharmaceutical compounds. These detection techniques were used in the analysis of multiple lots of PEG reagents. CAD was found to provide more accurate impurity and polydispersity profiles of PEG reagents that better differentiate their quality, while RI was not suitable for this application due to its low sensitivity and ELSD led to underestimation of the impurity and polydispersity. The accuracy of polydispersity determination by SEC-CAD was validated against a commercial reference standard of known polydispersity. The SEC-CAD technique and the observed differences between the three detectors can also be applied to polymer analysis in general.
authors.affiliation: Department of Pharmaceutical and Analytical Research & Development, Hoffmann-La Roche Inc., 340 Kingsland Street, Nutley, NJ 07110, USA. dawen.kou@roche.com
authors.forename: Dawen
authors.initials: D
authors.lastname: Kou
authors.forename: Gerald
authors.initials: G
authors.lastname: Manius
authors.forename: Shangdong
authors.initials: S
authors.lastname: Zhan
authors.forename: Hitesh P
authors.initials: HP
authors.lastname: Chokshi
mesh_terms: D000336:Aerosols / Q000737:chemistry*; D002850:Chromatography, Gel / Q000295:instrumentation / Q000379:methods; D004340:Drug Contamination; D008027:Light; D016014:Linear Models; D008970:Molecular Weight; D011092:Polyethylene Glycols / Q000032:analysis*; D012031:Refractometry / Q000379:methods; D015203:Reproducibility of Results; D012542:Scattering, Radiation; D012680:Sensitivity and Specificity
chemical_list: D000336:Aerosols; D011092:Polyethylene Glycols