title: Simultaneous determination of polysorbate 20 and unbound polyethylene-glycol in protein solutions using new core-shell reversed phase column and condensation nucleation light scattering detection.
abstract: A novel fast and sensitive method has been developed for the specific simultaneous determination of polysorbate 20 (Tween 20) and unbound polyethylene-glycol (PEG) from liquid formulations in the presence of proteins and excipients. The quantitative determination is based on a fast liquid chromatographic (HPLC) separation and condensation nucleation light scattering detection (CNLSD or NQAD™). The method uses a Kinetex core-shell column (100 mm × 3 mm, 2.6 μm) and methanol-water-trifluoroacetic acid mobile phase. The rapid HPLC-CNLSD method presented here is suitable for quantifying polysorbate 20 in the range of 10-60 μg/ml and unbound PEG in the range of 2-40 μg/ml in protein solutions within good manufacturing practices (GMP) of the pharmaceutical industry.
authors.affiliation: Formulation Development, Gedeon Richter Plc, Budapest X., Gyömroi út 19-21, Hungary. fekete.szabolcs1@chello.hu
authors.forename: Szabolcs
authors.initials: S
authors.lastname: Fekete
authors.forename: Katalin
authors.initials: K
authors.lastname: Ganzler
authors.forename: Jeno
authors.initials: J
authors.lastname: Fekete
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D008027:Light; D016014:Linear Models; D011092:Polyethylene Glycols / Q000032:analysis* / Q000737:chemistry; D011136:Polysorbates / Q000032:analysis* / Q000737:chemistry; D011506:Proteins; D015203:Reproducibility of Results; D012542:Scattering, Radiation; D012680:Sensitivity and Specificity; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; D013696:Temperature
chemical_list: D011136:Polysorbates; D011506:Proteins; D011092:Polyethylene Glycols