CRITICAL ISSUES IN CHIRAL DRUG ANALYSIS IN BIOLOGICAL-FLUIDS BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY

This review article focuses on the specificities of chiral liquid chro matography, with particular emphasis on stability, stereoconversion, e nantiomeric separation, recovery and drug concentration determinations . In addition, the paper presents an overview of the different steps w hich have to be followed for a chiral method to be validated. Sensitiv ity, selectivity, linearity, precision and accuracy all have to be ens ured for three chemical entities, the two enantiomers and the racemate . Only accurate and precise concentrations of the parent drug and its metabolites will lead to the reliable description of their in vitro st ability and in vivo body disposition.