Temperature Dependence On Reversed-Phase Separations Of Fatty Acid Modified GLP-1 Receptor Agonists And Their Impurities

By Caitlin M. Hanna, Stephan M. Koza, and Steve Shiner, Waters Corporation

The reversed-phase separation of fatty acid-modified GLP-1 receptor agonists (GLP-1 RAs) and their associated impurities is shown to be highly sensitive to column temperature. Our findings demonstrate that temperature plays a critical role in modulating the chromatographic behavior of these compounds, significantly influencing the resolution between the active pharmaceutical ingredient and structurally similar impurities. By carefully adjusting the column temperature, it is possible to enhance the separation of critical impurity species, thereby improving the overall analytical performance of the method. These results underscore the importance of maintaining strict temperature control during reversed-phase separations of fatty acid-modified GLP-1 RAs. Consequently, when selecting instrumentation for such analyses, the system’s ability to precisely regulate and maintain column temperature should be a key consideration to ensure reproducibility and optimal resolution.

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