A highly sensitive high-performance liquid chromatography-charged aerosol detection method for the quantitative analysis of polysorbate 80 in protein solution

Goal

To describe the development of a highly sensitive charged aerosol detection (CAD) method for the determination of polysorbate 80, also known as Tween™ 80, in biopharmaceutical products.

Introduction

Polysorbates, such as polysorbate 20 and polysorbate 80, are non-ionic surfactants. They are commonly used in biotherapeutic formulations to prevent surface adsorption and stabilize proteins against aggregation induced by stress, such as agitation and shear.1 For quality control purposes, it is important to determine the concentration of polysorbate in the final products. However, the quantitative analysis of polysorbate is challenging—polysorbate is a complex mixture of many different species, which lack natural UV chromophores, and is therefore difficult to analyze by UV detection. Also, chromatographic separation often leads to peaks or peak groupings that consist of many unresolved components and poor peak shapes, thus making accurate and sensitive quantitation problematic.

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