Enantiomeric separation of denopamine by capillary electrophoresis and high-performance liquid chromatography using cyclodextrins.

Direct separation of enantiomers of denopamine was investigated by two separation methods. One is capillary zone electrophoresis (CZE) using cyclodextrins (CDs) (CD-CZE) and the other is high-performance liquid chromatography (HPLC) using CD immobilized chiral stationary phases (CD-CSPs). Enantiomers of denopamine were successfully resolved by employing heptakis (2,6-di-O-methyl)-beta-cyclodextrin (DM-beta-CD) and acetyl-beta-cyclodextrin (AC-beta-CD), and partially resolved with heptakis(2,3,6-tri-O-methyl)-beta-cyclodextrin (TM-beta-CD), hydroxypropyl-beta-cyclodextrin (HP-beta-CD) and beta-CD polymer under acidic conditions. Separation of enantiomers of denopamine by HPLC was also successful with one of the CD-CSPs, where perphenylated beta-CD (Ph beta-CD) was immobilized. In CD-CZE, some polymeric additives, such as hydroxy-propylmethylcellulose (HPMC) and polyvinylalcohol (PVA), and a coated capillary were used to improve the enantioseparation of denopamine. Method validations such as linearity, recovery and repeatability, etc., were investigated for HPLC, and the method was applied to the optical purity testing of the drug substances and in tablet form.