Chiral chromatographic screens in pharmaceutical analysis and purification

ANYL 405

Ricardo Borjas, ricardo.e.borjas@pfizer.com, Robert DePianta, and Ernest Pollard. Research Analytical, Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340
The pharmaceutical industry strives to produce effective, safe and high quality medicines. As part of the continuing effort to improve safety and efficacy of drugs, special attention of both pharmaceutical companies and regulatory agencies has been focused on chiral drugs. Because each enantiomer has the potential to produce different therapeutic or adverse effects, and may be even metabolized differently; hence, the analyst plays a critical role in the chiral discovery process. Chiral Chromatography, analytical and preparative, is considered now an intricate part of pharmaceutical analysis and drug discovery. We have developed and established a series of chiral HPLC (normal, polar and reverse phases) and chiral SFC screens that allow us to scout many conditions and colums rapidly and effectively. Emphasis will be given to our parallel chiral HPLC system and the chiral SFC. Furthermore, we will present the knowledge gained from common analytes tested in both chromatographic systems and modes to determine their differences and similarities with respect to column(s) performance. This knowledge is fedback to our screens to keep them efficient and productive. Several examples illustrating the performance of the screens will be discussed in detail.