장유란 (써모피셔사이언티픽)

장유란 (써모피셔사이언티픽)

이정향 (써모피셔사이언티픽)

권한순 (써모피셔사이언티픽)

Glucagon-like peptide-1 (GLP-1) receptor agonists are widely used peptide therapeutics for the treatment of type 2 diabetes and obesity. As the development of GLP-1 analogs expands, comprehensive characterization of product-related impurities and degradation products has become essential for ensuring product quality and stability. Because peptide therapeutics are susceptible to oxidation, truncation, and amino acid deletion, robust analytical strategies are required for impurity characterization. In this study, an Orbitrap-based high-resolution mass spectrometry (HRMS) workflow was applied to characterize degradation products generated under thermal and oxidative stress conditions. Chromatographic separation was achieved using a peptide reversed-phase column with MS-compatible mobile phases, followed by high-resolution full-scan MS and data-dependent MS/MS analysis. BioPharma Finder™ software was used for automated sequence annotation, modification site localization, and relative abundance assessment. The workflow enabled the characterization of multiple degradation products, including oxidized variants, truncated peptides, and deletion products. High-resolution accurate-mass data together with MS/MS fragmentation provided confident structural assignment, while software-assisted processing improved data interpretation and reporting efficiency. This analytical strategy provides a reliable approach for impurity characterization of GLP-1 peptide therapeutics and supports analytical development, stability assessment, and quality control.

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