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, J. Fekete

Research output: Contribution to journalArticle

12 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 - Oct 2010

Fingerprint

Polysorbates
Distillation columns
Light scattering
Condensation
Nucleation
Light
High Pressure Liquid Chromatography
Trifluoroacetic Acid
Proteins
Excipients
Drug Industry
Liquids
Methanol
Water
Pharmaceutical Preparations
Industry

Keywords

  • CNLSD
  • Fast chromatography
  • Kinetex
  • NQAD
  • PEG
  • Tween 20

ASJC Scopus subject areas

  • Analytical Chemistry
  • Organic Chemistry
  • Biochemistry

Cite this

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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.",
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AU - Ganzler, Katalin

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