Fast enantioselective separation of clevidipine and a dihydropyridine substituted acid by SFC on Chiralpak AD.

Conditions for the fast separation of the enantiomers of a dihydropyridine substituted acid on a 50 x 4.6 mm ID short Chiralpak AD column with 2-propanol modified carbon dioxide as the mobile phase are presented. A high throughout of samples can be accomplished through the continuous sample loading of the loop of the injector. If a continuous data collection was used 10 separations could be performed in about 5 min with a precision of 0.6% RSD for the area ratio (n = 10). The parent drug clevidipine can also be analyzed and its enantiomeric composition determined after alkaline hydrolysis into its acid, either through hydrolysis followed by extraction to dichloromethane or by direct analysis of the hydrolysis media. About 1 min is required for each run. Using 0.1 M of methanolic sodium hydroxide 2 min are sufficient for the hydrolysis, and, including weighing, only 5 min are required to analyze clevidipine.