Quality by Design in Pharmaceutical Analysis Using Computer Simulation with UHPLC
In this study, the quality-by-design principle is applied instead of trial-and-error in the development of a liquid chromatography (LC) method. A mixture of an active pharmaceutical ingredient and its 13 impurities was analyzed on a short narrow-bore column (50 mm ? 2.1 mm, packed with sub-2-?m particles) providing short analysis times. The performance of commercial modelling software for robustness testing was systematically compared to experimental measurements and design-of-experiment–based predictions.