Transfer and Scaling of a USP Assay for Quetiapine Fumarate across Liquid Chromatographic Systems

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Amanda B. Dlugasch, Jennifer Simeone, Zhimin Li, and Patricia R. McConville
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In this study, the USP assay method for quetiapine fumarate, an anti-psychotic drug, will be evaluated on a wide range of systems including an HPLC, a UHPLC and a UPLC liquid chromatographic system. This isocratic method will be evaluated under the conditions as stated per the USP Monograph: Quetiapine Fumarate (USP40- NF35 Page 5939). After testing the original method on all systems, the method will be scaled following the USP allowable changes. The results will demonstrate the ability to decrease run times and improve throughput by scaling a method to smaller particle size and column dimensions.

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