Aggregate Analysis Of Semaglutide Using A Biozen dSEC-1 SEC Column

By Sujatha Chilakala, Ph.D., and Lucia Geis-Asteggiante, Ph.D.

This content is brought to you by Phenomenex, a Danaher Operating Company.

Semaglutide, a synthetic peptide therapeutic used for managing type 2 diabetes and obesity, is susceptible to aggregation, which can reduce its safety and efficacy. Monitoring this aggregation is critical, typically performed using Size Exclusion Chromatography (SEC). However, the hydrophobic nature of Semaglutide often necessitates mobile phases containing organic solvents and acidic conditions to ensure accurate resolution.

This application note demonstrates successful aggregate analysis of Semaglutide using a Biozen dSEC-1 SEC column. This column's hydrophilic stationary phase is highly inert, reducing non-specific interactions and the need for organic solvents in the mobile phase. The method achieved effective separation of the monomer and two aggregate peaks in a 12-minute run. Key performance parameters, including resolution (3.16 to 3.36) and excellent retention time/peak area reproducibility (RSD ≤ 0.28% and 4.02%, respectively), were achieved for samples before and after photoinduced stress. Discover how this column offers a robust and reproducible method for critical Semaglutide aggregate studies.