Comparative study of amylose and cellulose derivatized chiral stationary phases in the reversed-phase mode

A direct, isocratic, and simple reversed-phase HPLC method was described fo r the separation of enantiomers, the newly synthesized potential drug subst ance and corresponding optical impurity, employing polysaccharide-based chi ral stationary phases (Chiralpak AD-RH and Chiralcel OD-RH). A baseline sep aration was attained with both columns. These two chiral stationary phases exhibit opposite chiral discrimination patterns concerning the elution orde r of enantiomers. Chiralpak AD-RH is more suitable for resolving the enanti omers. Low level quantification (0.05%) of the minor enantiomer is achieved. The a nalytical procedure was successfully applied to the detection of the optica l impurity in a potential drug substance. The minor enantiomer was not dete rmined quantitatively because of a trace level of it in the potential drug substances.