Scaling of a USP Assay for Quetiapine Fumarate Across Different LC Systems

In this study, the Waters Columns Calculator will be used to scale the USP monograph assay method for quetiapine fumarate an anti-psychotic drug, to smaller particle sized columns.

Utilizing the method scaling guidelines within the USP General Chapter <621>, traditional isocratic HPLC methods are capable of being scaled to columns with smaller particle sizes and shorter lengths. Scaling a USP method enables the use of modern chemistries and LC hardware to deliver improved throughput with decreased solvent consumption all while providing accurate and reproducible chromatographic data. The scaled modifications for the USP quetiapine fumarate assay method enabled the original method run time to be reduced by 57% for a 3 μm column on an ACQUITY Arc UHPLC System and 87% reduction for the 1.7 μm column on an ACQUITY UPLC H-Class PLUS System. The scaled methods maintained the same or improved chromatographic performance in terms of resolution, peak tailing, and retention time and peak area RSD.