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Profiling polysorbate 80 components using comprehensive liquid chromatography-tandem mass spectrometry analysis.

Yutaka Konya¹, Ryosuke Ochiai¹, Satoshi Fujiwara¹

¹Pharmaceuticals and Life Sciences Division, Shimadzu Techno-Research, Inc., Kyoto, Japan.

Rapid Communications in Mass Spectrometry : RCM

|November 21, 2022

Summary

A new liquid chromatography-tandem mass spectrometry (LC-MS/MS) method accurately profiles Polysorbate 80 (PS80) components. This advanced technique offers improved quality control for pharmaceutical formulations by revealing potential underestimations in fatty acid analysis.

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OLIgo Mass Profiling OLIMP of Extracellular Polysaccharides

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Published on: June 20, 2010

Area of Science:

Analytical Chemistry
Pharmaceutical Science

Background:

Polysorbate 80 (PS80) is a crucial surfactant in pharmaceutical protein formulations.
Commercial PS80 contains impurities, complicating component analysis due to its heterogeneous nature.

Purpose of the Study:

To develop a comprehensive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for profiling PS80 components.
To accurately estimate the average degree of ethylene oxide polymerization (Avg-n) and fatty acid (FA) composition ratios in PS80.

Main Methods:

Developed and applied a comprehensive LC-MS/MS method for PS80 analysis.
Analyzed 11 subspecies across three commercial PS80 products.
Quantified Avg-n values and the composition ratios of seven ester-bonded FAs.

Main Results:

Determined Avg-n values for various polyoxyethylene sorbitan, isosorbide, and ester subspecies.
Observed consistent FA composition ratios across different subspecies within each product.
Found higher C18:2 (linoleic acid) values than reported in product certificates.

Conclusions:

The LC-MS/MS method provides a reliable evaluation of PS80 components.
The study suggests conventional gas chromatography-mass spectrometry may underestimate ester-bonded linoleic acid.
The developed method can enhance PS80 quality control in pharmaceutical formulations.