Method for simultaneous quantification of lipid and nucleic acid components in lipid nanoparticle formulations

Abstract

The present disclosure relates to methods for quantifying both lipid and nucleic acid cargo components of LNP formulations simultaneously, i.e., in a single chromatography separation process. In some embodiments, the methods comprise ion-pair reversed-phase high performance liquid chromatography (IPRP-HPLC) separation coupled with ultraviolet (UV) and charged aerosol detection (CAD). In some cases, the methods allow for quantification of the content of several different lipid and nucleic acid species in a single LNP formulation simultaneously, thus allowing for efficient characterization of LNP formulations, for example, for process control of pharmaceutical or test formulations.

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