Monitoring of the optical purity for dexibuprofen by HPLC

Two enantiomers of chiral drugs often differ substantially in their pharmacological, toxicological pharmacokinetic profile. Ibuprofen is a nonsteroidal antiinflammatory drug (NSAID) and has a chiral center. Between the two enantiomers of ibuprofen, (S)-ibuprofen (called dexibuprofen) is more effective, and the more active dexibuprofen was commercialized in our country recently. In this study, the optical purity of sixteen commercialized dexibuprofens prepared from nine Korean drug companies were examined by an optimized chiral HPLC condition. The Chiralcel OD column was used as a chiral stationary phase and the mixed eluent of hexane, isopropanol, and acetic acid as 100 : 1 : 0.1 was used as a mobile phase with a flow rate of 1.0 mL/min. Each data was obtained from an average value of at least three different experiments for each sample and the relative standard deviation of them appeared very small. Optical purity values of most commercialized dexibuprofens used in this study were higher than 99 percents.