Implementation of a rapid and automated high performance liquid chromatography method development strategy for pharmaceutical drug candidates

A comprehensive, fully automated strategy is demonstrated for HPLC-UV chromatographic method development using ChromSword® optimization software. The strategy involves: (1) the automated screening of various column and mobile phase combinations, (2) rational selection of the best starting conditions; and (3) subsequent automated method development to generate optimized separation methods. Pharmaceutical compounds were applied to solve problematic drug impurity separations. ChromSword® software automates the screening, optimization, and documentation steps thus reducing the method development time. The strategy was compared to a manual method development approach showing the automated method strategy affords better selectivity in a shorter time.