Improvements to PS80 Detection in Drug Product Formulations

Excipients play an essential role in drug formulations — serving as binders, disintegrants, stabilizers, or pH adjusters for proper dosage form performance. Some of the most common excipients in biotherapeutic formulations are non-ionic surfactants, such as polysorbates, specifically PS80 and PS20 (Tween 80 and Tween 20). For quality control and overall public health and safety, it is important to have analytical assays that can accurately measure excipient levels in samples of interest.

Analysis of these small molecules has several pressing challenges. For example, polysorbates are highly heterogeneous, and these molecules lack a chromophore, making UV detection impractical.

However, there are decided benefits to a mixed-mode high-performance liquid chromatography (HPLC) method, as opposed to a traditional reverse-phase HPLC method.  This white paper offers an explanation and data illustrating the benefits of a mixed-mode HPLC approach, including: