Rapid enantiomeric separation and quantitation of levetiracetam on α-acid glycoprotein (AGP) chiral stationary phase by high-performance liquid chromatography

Abstract

A new, simple, and rapid chiral HPLC method was developed for enantioselective analysis of levetiracetam and its enantiomer [(R)-α-ethyl-2-oxo-pyrrolidine acetamide] in a pharmaceutical formulation and bulk material. Enantiomeric separation was achieved on a chiral-α1-acid glycoprotein (AGP) column (150 × 4.0 mm, 5 μm) 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 μg/mL and 0.4-20 μg/mL for levetiracetam and the (R)-enantiomer, respectively. LOD and LOQ for the (R)-enantiomer were 0.1 and 0.4 μg/mL, respectively. The run time of analysis was less than 5.0 min.