Development of High-Performance Separation Methods for New Modality Pharmaceuticals Including Nanomedicines

In recent years, innovative pharmaceuticals such as nanotechnology-based pharmaceuticals (nanomedicines) and mid-sized pharmaceuticals have been developed. In particular, nanomedicines have contributed significantly to the rapid dissemination of COVID-19 vaccines and may continue to be an essential formulation technology for the development of vaccines against various infectious diseases and cancers. Because chromatography is a major analytical technique for pharmaceuticals, it is important to develop a high-performance separation method for innovative pharmaceuticals with unconventional characteristics using this technique. We have promoted research focused on the development of high-performance separation and analysis methods for nanomedicines and mid-sized pharmaceuticals using chromatography. In this review, the author presents our related research achievements on: (1) the development of a size separation method for nanoparticles using monolithic capillary columns, (2) the development of a size separation method for liposome formulations using monolithic capillary LC, (3) size exclusion chromatography (SEC)-multi-angle light scattering (MALS) detector for block copolymer micelle characterization, (4) development of a highly sensitive method for measuring concentrations of the anticancer drug doxorubicin and its metabolites in biological samples, (5) development of a high-resolution analytical method for cyclosporine.