The Chromatography Forum

of Delaware Valley

 Chiral Chromatography Method Screening Strategies - Experimental and Computational

Analysis and control of chiral impurities is an important task in pharmaceutical analysis. The chiral method development usually starts with screening of chiral stationary phases (CSP). In this presentation, we are taking a deep dive in chiral HPLC method screening strategy from both experimental and computational angles. We have systematically studied the performance of popular polysaccharide CSPs in separating chiral impurities in compounds with a single or multiple chiral centers. We will discuss the important practical aspects in chiral method screening including selection between immobilized and coated CSPs,  SFC and RP-HPLC,  isocratic and gradient screening, and sub-2 um and 3-um particle sizes, to define a successful data-driven HPLC screening strategy. Furthermore, we will discuss the machine learning approach in CSP selection based on the compound chemical structure.