Successful Method Migration Of The USP Quetiapine Fumarate Impurities Method To An Alliance™ iS HPLC System

By Amanda B. Dlugasch, Lise Gauthier, Paula Hong

In regulated laboratories, method migration—the process of transferring an established method from one HPLC system to another—is a common and crucial task. This is often necessitated by the presence of diverse HPLC instrumentation from various vendors or the need to upgrade older equipment to meet increasing throughput demands. However, method migration can be challenging due to potential differences in instrumentation that may impact chromatographic results.

The Alliance iS HPLC System is designed with features specifically tailored to facilitate successful method migration. This application note explores how the Alliance iS system's key elements can help achieve consistent or even improved results during method transfer.

To demonstrate the system's capabilities, we analyzed the USP method for Quetiapine Fumarate Impurities on two legacy HPLC systems and then on the Alliance iS HPLC System. Using an unknown sample of the drug substance, we compared the results and evaluated the system's performance against the USP method's system suitability requirements.