Method for separating and determining Pregabalin and chiral isomers thereof

The invention relates to a method for derivatizing and separating and determining Pregabalin and chiral isomers thereof. In the method provided by the invention, Nalpha-(5-fluor-2,4-dinitrophenyl)-D-amino acids and the Pregabalin undergo quick derivatization under microwave-assisted condition in a non-protonic organic solvent with high boiling point; and after the reaction is finished, derivatives are separated and determined by adopting achiral high performance liquid chromatography or combining the achiral high performance liquid chromatography with mass spectrum. The method provided by theinvention is suitable for separating and determining the Pregabalin and the chiral isomers thereof, particularly for separating and determining Pregabalin medicaments or preparations containing tracechiral isomers of the Pregabalin. The method has the characteristics of higher detection sensitivity, lower cost, simple and quick analysis process, combination of the achiral high performance liquidchromatography with the mass spectrum more suitable for the used mobile phase, and the like.