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Transfer of USP Assay for Quetiapine Fumarate Across Different LC Systems

17 Sept 2018

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.

Waters Alliance™ HPLC System

Waters

An integrated HPLC system that works as hard as you do, available with push-button mass detection for the chromatographer. The Alliance™ HPLC System is the flexible and reliable workhorse that meets your fundamental HPLC separation requirements. The system has been continually expanded and perfected to accommodate an enormous range of real-world analytical challenges, culminating in today’s new industrial design which signifies Waters’ commitment to HPLC and our HPLC line. Today, users can extend the Alliance HPLC System’s performance with XP 2.5 µm Columns. XP Columns are compatible with both HPLC and UPLC technology and are designed to not only improve our HPLC productivity, but also facilitate a transfer to UPLC Technology platforms as well. Directly scalable between UPLC and HPLC particle sizes, these new 2.5 um XP Columns bridge the gap between HPLC and UPLC performance. Whether your lab analyzes samples in the pharmaceutical, chemical, food safety, environmental, or quality control arenas, the Alliance HPLC system offers you a field-proven solution. Integrated solvent and sample management to ensure consistent system-to-system performance and high reproducibility. Waters Alliance™ HPLC System Features: Full integration with either Empower® or MassLynx® Software for instrument control and data processing A large, intuitive LCD-based user interface allows rapid system set-up through SystemPREP routines that streamline daily start-ups Easy, tool-free maintenance resulting in maximized uptime Waters complete line of detection technologies – from routine UV/Vis detectors, to the ACQUITY QDa Detector to single, tandem and triple quadrupole mass spectrometers - extend your application capabilities

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Transfer of USP Assay for Quetiapine Fumarate Across Different LC Systems