Literature DB >> 20307948

Fast and sensitive determination of Polysorbate 80 in solutions containing proteins.

Szabolcs Fekete1, Katalin Ganzler, Jeno Fekete.   

Abstract

A fast and sensitive method has been developed for the specific determination of Polysorbate 80 (Tween 80) in liquid formulations in the presence of proteins and excipients. The quantitative determination is based on a fast liquid chromatographic (HPLC) separation and charged aerosol detection (CAD). The method was validated using a Poroshell 300SB-C18 column packed with 5 microm shell particles (75 mm x 2.1 mm) and acetonitrile-methanol-water-trifluoroacetic acid mobile phase at a flow rate of 0.65 ml/min. The rapid LC-CAD method is suitable for quantifying Polysorbate 80 in the range of 10-60 microg/ml in protein solutions within good manufacturing practices (GMPs) of the pharmaceutical industry. 2010 Elsevier B.V. All rights reserved.

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Year:  2010        PMID： 20307948     DOI： 10.1016/j.jpba.2010.02.035

Source DB:  PubMed          Journal:  J Pharm Biomed Anal        ISSN： 0731-7085            Impact factor:   3.935


  7 in total

1.  Evaporative light scattering detection based HPLC method for the determination of polysorbate 80 in therapeutic protein formulations.

Authors:  Vikram S Nayak; Zhijun Tan; Peter M Ihnat; Reb J Russell; Michael J Grace
Journal:  J Chromatogr Sci       Date:  2012-01       Impact factor: 1.618

2.  Universal method for the determination of nonionic surfactant content in the presence of protein.

Authors:  Ziping Wei; Susanna Bilbulian; Jingning Li; Ratnesh Pandey; Ellen O'Connor; Jose Casas-Finet; Patricia W Cash
Journal:  J Sep Sci       Date:  2015-03-03       Impact factor: 3.645

3.  Protein Formulations Containing Polysorbates: Are Metal Chelators Needed at All?

Authors:  Ema Valentina Brovč; Stane Pajk; Roman Šink; Janez Mravljak
Journal:  Antioxidants (Basel)       Date:  2020-05-20

4.  Anaerobic growth of Saccharomyces cerevisiae CEN.PK113-7D does not depend on synthesis or supplementation of unsaturated fatty acids.

Authors:  Wijb J C Dekker; Sanne J Wiersma; Jonna Bouwknegt; Christiaan Mooiman; Jack T Pronk
Journal:  FEMS Yeast Res       Date:  2019-09-01       Impact factor: 2.796

5.  Polysorbate 80 and histidine quantitative analysis by NMR in the presence of virus-like particles.

Authors:  Richard R Rustandi
Journal:  Electrophoresis       Date:  2022-04-26       Impact factor: 3.595

6.  Critical parameters and procedures for anaerobic cultivation of yeasts in bioreactors and anaerobic chambers.

Authors:  Christiaan Mooiman; Jonna Bouwknegt; Wijb J C Dekker; Sanne J Wiersma; Raúl A Ortiz-Merino; Erik de Hulster; Jack T Pronk
Journal:  FEMS Yeast Res       Date:  2021-06-21       Impact factor: 2.796

Review 7.  Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques.

Authors:  Elena Hipper; Michaela Blech; Dariush Hinderberger; Patrick Garidel; Wolfgang Kaiser
Journal:  Pharmaceutics       Date:  2021-12-28       Impact factor: 6.321
  7 in total

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