Chiral bioanalysis

This chapter discusses chiral bioanalysis and the developments in the field, focusing mainly on the techniques used in high-performance liquid chromatography (HPLC) and providing a brief introduction to bioanalytic applications in gas chromatography (GC), capillary electrophoresis (CE), and supercritical fluid chromatography (SFC). It includes a review of the principle types of chiral stationary phases (CSPs), their mechanism of action, typical mobile phase choices, and applicability. A method of choice must be sufficiently robust to withstand large numbers of biologic samples. It must be capable of method transfer to other research laboratories such as a contract laboratory facility, as the drug development process progresses. New chemical entity submissions to the FDA and other organizations around the world also need to incorporate validated data using freely available methods. Direct HPLC methods (rather than the use of achiral stationary phases with chiral additives or derivatization of the solute with chiral reagents) are generally preferred in pharmaceutical research. It is mainly for these reasons that HPLC (and in particular HPLC–mass spectrometry, MS–MS) is a main focus of this chapter. It is also for these reasons that the chapter only presents commercially available and proven technologies.