Glucagon-Like Peptide-1 agonists (GLP-1s) are a class of synthetic peptide medications that are prescribed for the treatment and management of obesity and type-II diabetes. Recently, drugs such as semaglutide, have boomed in popularity as a weight management treatment after success in clinical trials. Given the prevalence of GLP-1s, it is important that the quality control for this class of pharmaceuticals is supported by versatile, sensitive, and reproducible chromatography methods. While there are chromatographic methods for some of the common GLP-1s, to our knowledge, there is not a single method to separate an updated panel of this class of synthetic peptides. Further, the U.S. Food and Drug Administration (FDA) recently released Product Specific Guidelines (PSG) for some of the synthetic peptides on the market. In this presentation, the FDA states the importance for impurity analysis of synthetic peptides.

In the work shown here a single HLPC-UV/MS method was developed for the analysis of a variety of GLP-1s and associated impurities utilizing a systematic protocol in combination with a novel surface modification technology based on hybrid organic/inorganic surface based on an ethylene-bridged siloxane chemistry. This technology has previously been shown to mitigate undesirable metal and peptide interactions leading to improvements in chromatographic separation parameters such as chromatographic peak area count, tailing and retention time reproducibility.