Transfer of USP Assay for Quetiapine Fumarate Across Different LC Systems

In this study, the USP assay method for quetiapine fumarate, an anti-psychotic drug, will be evaluated on a range of systems including an Alliance HPLC System, an ACQUITY Arc UHPLC System and an ACQUITY UPLC H-Class PLUS System. The USP method for quetiapine fumarate was successfully transferred across three systems: an Alliance HPLC System, an ACQUITY Arc UHPLC System, and also an ACQUITY UPLC H-Class PLUS System. All three instruments were able to reproduce the percent of quetiapine fumarate in an unknown sample and meet system suitability requirements, including resolution, tailing factor, and repeatability specifications required by the USP quetiapine fumarate assay method.