Abstract: A method of capillary zone electrophoresis (CZE) has been established for the chiral separation of pitavastatin calcium enantiomers. Several parameters, such as the running voltage, the composition and the pH value of the running buffer, the types of additive and so on, were evaluated. The optimal separation conditions were as follows: capillary, 53 cm (45 cm effective length, 50 μm); running buffer, 80 mmol/L Tris-HCl, pH 3.20, which contained 50 mmol/L HP-β-CD (hydroxypropyl-β-cyclodextrin) and 5 mmol/L SDS (sodium dodecylsulphate); applied voltage, 18 kV (54 μA); column temperature, 23 ℃; injection, 2 s at the height of 17 cm. Under these conditions, pitavatatin calcium enantiomers were separated well with the resolution of 2.17. The results indicate that this method is rapid, simple, accurate and suitable for the chiral separation of pitvatin calcium enantiomers.

Key words: chiral separation, enantiomers, pitavastatin calcium, capillary zone electrophoresis (CZE)