Aggregate Analysis Of Tirzepatide 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.

Tirzepatide, a dual GIP and GLP-1 receptor agonist used for managing type 2 diabetes and obesity, is a large, hydrophobic peptide prone to aggregation under various stress conditions. Since aggregation can compromise product safety and efficacy, detecting and quantifying it is a critical step in quality control.

Size Exclusion Chromatography (SEC) is the established technique for monitoring aggregation, but the hydrophobic and ionic nature of peptides like Tirzepatide can lead to non-specific interactions, requiring mobile phases with high organic solvents and acidic conditions for accurate results.

The Biozen dSEC-1 SEC column offers an inert, hydrophilic stationary phase that significantly reduces the need for organic solvents in the mobile phase, thereby simplifying method development and improving chromatographic performance. This technical note demonstrates successful and reproducible separation and quantification of Tirzepatide monomer and aggregate, both in the final product and after light-induced stress, using a mobile phase with moderate organic content (30% acetonitrile).

Discover the full chromatographic data, including excellent resolution and reproducibility for aggregate analysis, by accessing the complete application note.