Advances in capillary electrophoresis-mass spectrometry for pharmaceutical analysis

Abstract

Capillary electrophoresis-mass spectrometry (CE-MS) combines the high separation efficiency of capillary
electrophoresis with the exceptional sensitivity and specificity of mass spectrometry. CE-MS has gained significant
traction in pharmaceutical analysis, offering unique advantages in the analysis of pharmaceuticals, biologics, and
their metabolites. Recent technological advancements have enhanced CE-MS applicability, addressing historical
challenges in interface design and improving system robustness and sensitivity. Novel capillary coatings and
background electrolytes have expanded the range of analyzable compounds. CE-MS is utilized across various stages
of drug development and quality control, proving valuable in small-molecule drug analysis, and offering highresolution
separations of structural isomers and chiral compounds. In biopharmaceuticals, CE-MS has emerged as a
powerful tool for characterizing complex protein therapeutics, including monoclonal antibodies and biosimilars. The
technique provides detailed information on post-translational modifications and higher-order structures, ensuring
biologic drug quality and safety. CE-MS has shown potential in metabolomics, contributing to drug metabolism
understanding and biomarker discovery. The technique’s minimal sample and solvent requirements align with green
analytical chemistry principles. Ongoing research focuses on improving sensitivity, throughput, and data analysis
capabilities. Integration with other analytical techniques and advancements in bioinformatics tools are enhancing
CE-MS applications in pharmaceutical analysis, particularly in the era of personalized medicine and biologics.