title: An HPLC with evaporative light scattering detection method for the quantification of PEGs and Gantrez in PEGylated nanoparticles.
abstract: A rapid and precise HPLC method with evaporative light scattering detection (ELSD) for the separation and quantification of polyethyleneglycol 2000 (PEG 2000), polyethyleneglycol 6000 (PEG 6000) and poly(methyl vinyl ether-co-maleic anhydride) (Gantrez) in a nanosized pharmaceutical formulation has been developed. Separation was carried out on a PL aquagel-OH 30,8 microm column (300 mm x 7.5 mm), in a gradient elution with methanol-water as mobile phase at a flow rate of 1 ml/min. Quantification was determined in supernatants of PEGylated nanoparticles and the quantification limits were found to be 0.075 mg/ml for polyethyleneglycols and 0.25 mg/ml for Gantrez. The precision did not exceed 8% and accuracy range for PEGs (-11.50 and 10.61%) and Gantrez (-12.18 and 14.81%) were always within the acceptable limits. The amount of polyethyleneglycol associated to nanoparticles was also calculated by a Nuclear Magnetic Resonance Method ((1)H NMR). Likely, for both PEGs, a good relationship between both techniques was found. In summary, the developed HPLC technique provides an alternative for the routine and rapid analysis of PEGs and Gantrez in nanoparticle formulations.
authors.affiliation: Department of Pharmaceutical Technology, University of Navarra, Pamplona, Spain.
authors.forename: Virginia
authors.initials: V
authors.lastname: Zabaleta
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Campanero
authors.forename: Juan M
authors.initials: JM
authors.lastname: Irache
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D008027:Light; D009682:Magnetic Resonance Spectroscopy; D008298:Maleates / Q000032:analysis* / Q000737:chemistry; D008970:Molecular Weight; D053758:Nanoparticles / Q000032:analysis* / Q000737:chemistry; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D011092:Polyethylene Glycols / Q000032:analysis* / Q000737:chemistry; D011145:Polyvinyls / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D012542:Scattering, Radiation; D013997:Time Factors; D014835:Volatilization
chemical_list: D008298:Maleates; D004364:Pharmaceutical Preparations; D011145:Polyvinyls; C058026:polyvinylmethoxyethylene-maleic anhydride copolymer; D011092:Polyethylene Glycols