Comparison of various chiral stationary phases for the chromatographic separation of chiral pharmaceuticals

Many pharmaceuticals contain active ingredients that have more than one stereoisomer. An important concern is the recognition that these different stereoisomers do not necessarily have identical, or even desirable biological activity. Consequently, analytical methods for the analysis and separation of enantiomers are important in the proper development of a marketed pharmaceutical product. In this research, direct HPLC methods for the chromatographic separation of oxyphene optical isomers have been developed and optimized using three types of chiral stationary phases. The research carried out a systematic study of the conditions for the separation of oxyphene optical isomers using synthetic polymer chiral stationary phase of cellulose tris (3, 5-dimethylphenylcarbamate) Chiralcel OD, ß-cyclodextrin chiral stationary phase, and a1-acid glycoprotein chiral stationary phase. The methods using the ß-cyclodextrin and Chiralcel OD columns provide for the accurate determination of the optical purity (as low as 0.1%) of each enantiomer, in the presence of the other major enantiomer. The performance of these chiral stationary phases is also compared.