William R. Leonard

Rapid Analytical Method Development Using Multiparallel Microfluidic High-Performance Liquid Chromatography in Support of Pharmaceutical Process Research

Abstract Rapid chiral method development using microfluidic multiparallel HPLC is illustrated with several examples of ‘real world’ pharmaceutical intermediates for which speed was critical for successful process development. It is shown that this rapid chiral method development approach is suitable for support of high throughput screening of enantioselective catalytic hydrogenation reactions and other high throughput experimentation initiatives in pharmaceutical process research.

MODELING THE SELECTION OF FRACTIONS DURING PREPARATIVE HPLC OF A SEMISYNTHETIC PNEUMOCANDIN

Analytical high-performance liquid chromatography (HPLC) data collected during developmental scale-up studies were used to design an empirical model that was applied to the selection of HPLC fractions obtained during preparative scale reverse-phase HPLC of a semisynthetic lipopeptide antifungal. These data resulted in the ability to collect fractions containing the target compound at acceptable purity and with minimal yield loss, based on the ultraviolet data generated by the preparative column detector. The methodology used was successfully integrated from a developmental scale to a manufacturing scale.