A fast strategy for profiling and identifying pharmaceutic excipient polysorbates by ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry.

Polysorbates, a group of nonionic surfactants, are widely used as pharmaceutic excipient. Their quality and safety are closely related to their profiles, including composition, structure, proportion and polyoxyethylene (POE) polymerization degree. However, due to complex composition and similar skeletons, it is difficult and time-consuming to profile and identify them. There is no integrated strategy for routine control. In this paper, an UHPLC-HRMS method was established, and 211 components belonging to 10 species in polysorbate-80 were identified based on their MS/MS data and further confirmed by NMR. A mathematical model was then established to predict all possible components based on the good logarithmic relationship between the POE polymerization degrees and retention times (RTs) of the components for the first time. A database of 853 detected and predicted components of polysorbate-80, -60, -40 and -20 was created. A novel rapid identification strategy was established for comprehensive polysorbate profiling by comparing the exact masses and RTs of the test peaks to the database. This novel strategy was employed to profile polysorbates in 14 pharmaceutic excipients and preparations. Approximately 200 components were identified and semiquantified in each sample, and the number and content of components differed among these samples.