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Method Development: Quantitative Determination of Polysorbate 80 in Gammanorm® and Poloxamer 188 in Octagenate® Using Hydrophilic Interaction Liquid Chromatography Coupled with Evaporative Light Scattering Detection
Linnaeus University, Faculty of Science and Engineering, School of Natural Sciences.
2012 (English)Independent thesis Basic level (degree of Bachelor), 10 credits / 15 HE creditsStudent thesis
Abstract [en]

Polysorbate 80 (PS80) and Poloxamer 188 (P188) are non-ionic detergents used as surfactants in the injection fluids Gammanorm® (human immunoglobulin) and Octagenate® (recombinant human factor VIII) respectively.PS80 in Gammanorm® is currently quantified using a spectrophotometric method based on complexation with ammonium cobalt(II)-thiocyanate after a protein precipitation step with ethanol (T-603). Highly questionable performance of T-603 has led to the development of an analysis method based on hydrophilic interaction liquid chromatography (HILIC) with evaporative light scattering detection (ELSD). P188 in Octagenate® is currently quantified using HILIC-ELSD (Q-726), but recent problems with peak broadening, signal saturation and insufficient resolution have caused Q-726 to be placed on hold.The aim of this work was to solve the problems connected with Q-726, an analysis method for the quantitative determination of P188 in Octagenate®, and to develop a new analysis method for the quantitative determination of PS80 in Gammanorm® based on HILIC-ELSD.Optimization of ELSD parameters and increased water content in the mobile phase, proved effective in solving the problems with the analysis of P188. The lack of reproducible ethanol injections without interfering peaks prevented further advancement of the PS80 method development. Good results from analysis of standard injections of PS80 between 1 and 10 ppm in the PS80 method were obtained with good correlation (R2 > 0.99). The obtained results, in combination with a recently published article, describing a quantitative determination of PS80 in therapeutic protein formulations based on HPLC-ELSD, indicates potential for this method and further analysis should be performed to validate whether or not the method development is to be continued.

Place, publisher, year, edition, pages
2012. , 23 p.
Keyword [en]
Chromatography, Evaporative Light Scattering Detection, Gammanorm, Octagenate, Hydrophilic Interaction liquid chromatography
National Category
Biomedical Laboratory Science/Technology
Identifiers
URN: urn:nbn:se:lnu:diva-20231OAI: oai:DiVA.org:lnu-20231DiVA: diva2:535494
External cooperation
Octapharma AB
Subject / course
Biomedical Sciences
Educational program
Biomedical Laboratory Science Programme, 180 credits
Uppsok
Medicine
Supervisors
Examiners
Available from: 2012-06-21 Created: 2012-06-19 Last updated: 2012-10-08Bibliographically approved

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CiteExportLink to record
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Citation style
  • apa
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