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Abstract
A direct, isocratic, and simple reversed-phase HPLC method was described for the separation of enantiomers, the newly synthesized potential drug substance and corresponding optical impurity, employing polysaccharide-based chiral stationary phases (Chiralpak AD-RH and Chiralcel OD-RH). A baseline separation was attained with both columns. These two chiral stationary phases exhibit opposite chiral discrimination patterns concerning the elution order of enantiomers. Chiralpak AD-RH is more suitable for resolving the enantiomers.
Low level quantification (0.05%) of the minor enantiomer is achieved. The analytical procedure was successfully applied to the detection of the optical impurity in a potential drug substance. The minor enantiomer was not determined quantitatively because of a trace level of it in the potential drug substances.