Advancements in Liquid Chromatography Method Development for Pharmaceuticals

Pankaj Aggarwal, Kimber Barnett, James Morgado, Dave Fortin

Pfizer, Groton, CT  

Systematic LC method development approaches provide information that can be used to establish robust method conditions with controls that ensure consistent method performance throughout method lifecycle. These approaches are well established in pharmaceutical industry and have evolved based on scientific advances to meet the needs of increased speed and accuracy at lower cost. The retention time data from these systematic approaches may be used for structure based predictions or data driven robustness predications by implementation of modern day data visualization tools and statistical analysis. The data driven retention time models developed from method optimization data can serve as a substituent for experimental DOE to establish method robustness. Structure based prediction using the screening data can reduce the need of method re-development to accommodate the changes in product development. Structure based predictions can serve as feedback loop for the method development approaches making it much more cost and time effective.