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

Szabolcs Fekete, Katalin Ganzler, Jeno Fekete

Research output: Article

13 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)6258-6266
Number of pages9
JournalJournal of Chromatography A
Volume1217
Issue number40
DOIs
Publication statusPublished - okt. 1 2010

ASJC Scopus subject areas

  • Analytical Chemistry
  • Biochemistry
  • Organic Chemistry

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