Polysorbates are non-ionic surfactants widely used as excipients or inactive ingredients in food and pharmaceutical products. The quality and purity of excipients are critical to the safety the finished drug products and patients’ health and must be demonstrated using suitable and reliable test methods.<br/><br/>Due to the complex and heterogenous nature and lack of strong chromophore required for UV detection, the polysorbates analysis can be a challenging task. A variety of analytical techniques have been developed and applied to analyze and characterize major polysorbates subspecies, such as liquid chromatography (LC) combined with charged aerosol detector (CAD), evaporative light scattering detector (ELSD), and mass spectrometry. Several methods allow quantification of polysorbates as a single peak, but do not provide specificity for all free fatty acids. The U.S. Pharmacopoeia specifies a gas chromatography (GC) with flame ionization detector (FID) procedures for polysorbate 80 and 20 based on fatty acids composition by conversion of methylated acids to free fatty acids. This procedure requires hydrolysis and derivatization of the polysorbates to free fatty acids.<br/><br/>In this work, simple and fast HPLC methods coupled with mass detection for the analysis of polysorbates 80 and 20 are presented. The new methods offer accurate quality and purity assessment of polysorbates 80 and 20 pharmaceutical raw material by measuring fatty acids composition by direct analysis of hydrolyzed samples.

Quality assessment of polysorbates 80 and 20 pharmaceutical raw materials by measuring fatty acids composition using HPLC with mass detection

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