Analytical profiling and stability evaluation of liposomal drug delivery systems: A rapid UHPLC-CAD-based approach for phospholipids in research and quality control

[摘要] Phospholipids and their derivatives represent a broad range of multifunctional substances used as excipients or active ingredients by different industries due to their natural origin and unique properties. A fast and reliable quantification as well as comprehensive stability evaluation are of major importance in the process of development and quality control of lipid-based systems. Therefore, the present study is focused on the development and validation of a rapid ultra-high performance liquid chromatography - charged aerosol detector based (UHPLC-CAD) method for simultaneous detection of a multitude of natural and synthetic lipids, (charged) phospholipids, lipophilic fluorescent markers and their possible degradation products. Twenty-two compounds were characterized by a strong linear response of the detector (R-2 > 0.97). Moreover, remarkable limits of detection (<= 10 mu g mL(-1)) and limits of quantification (<= 25 mu g mL(-1)) associated with a consistent reproducibility were achieved for all tested molecules. The performance of the analytical method was demonstrated by analyzing the lipid composition (after different production stages and photodegradation) of both bupivacaine loaded liposomes and a Doxil (R)-like formulation. The newly developed method combines a rapid, comprehensive, and efficient quantification with minimal economic effort and ecologic consequences, meeting the requirements of modern analytical processes and offering a broad range of possible applications in various industrial sectors and scientific laboratories.

[发布日期] 2020-12-01

[关键词] UHPLC-CAD method;Phospholipid detection;Phospholipid quantification;Liposomes;Charged aerosol detector