Rapid Enantiomeric Separation and Quantitation of Levetiracetam on α-Acid Glycoprotein (AGP) Chiral Stationary Phase by High-Performance Liquid Chromatography

A new, simple, and rapid chiral HPLC method was developed for enantioselective analysis of levetiracetam and its enantiomer [(R)-alpha-ethyl-2-oxo-pyrrolidine acetamide] in a pharmaceutical formulation and bulk material. Enantiomeric separation was achieved on a chiral-alpha(1)-acid glycoprotein (AGP) column (150 x 4.0 mm, 5 pm) using an isocratic mobile phase of phosphate buffer (pH = 7) at a flow rate of 0.7 mL/min. The UV detector was set at 210 nm. Calibration curves were linear in the range of 1-100 mu g/mL and 0.4-20 mu g/mL for levetiracetam and the (R)-enantiomer, respectively. LOD and LOQ for the (R)-enantiomer were 0.1 and 0.4 mu g/mL, respectively. The run time of analysis was less than 5.0 min.