Enantioselective high-performance liquid chromatographic assay for determination of the enantiomers of a new anti-ulcer agent, E3810, in beagle dog plasma and rat plasma.

An enantioselective high-performance liquid chromatographic method for the determination of E3810, a new anti-ulcer agent, in Beagle dog plasma and rat plasma has been developed. After extraction from plasma with ethyl acetate, E3810 enantiomers were measured by reversed-phase high-performance liquid chromatography on a Chiralcel OD-R column. The enantiomers were detected by ultraviolet absorbance detection at 290 nm. The recoveries of E3810 enantiomers and internal standard were greater than 91%. The calibration curves were linear from 0.03 to 20 micrograms/ml for Beagle dog plasma and from 0.1 to 100 micrograms/ml for rat plasma. The limits of quantification of both enantiomers were 0.03 micrograms/ml for Beagle dog plasma and 0.1 micrograms/ml for rat plasma. The intra- and inter-day accuracy and precision data showed good reproducibility of the method. The assay was applied for the analysis of E3810 enantiomers in plasma after intravenous administration of racemic E3810 to Beagle dogs and rats. This method should be very useful for enantioselective pharmacokinetic studies of E3810.