Chiral Resolution and Content Determination of Ketorolac Tromethamine using High-performance Liquid Chromatography

Abstract

Establishing R, S-enantiomer (S-KT and R-KT) chiral resolution and determination methods for KT are of great significance. This study aimed to establish a high-performance liquid chromatog. (HPLC) method for the resolution and determination of ketorolac tromethamine (KT) enantiomers. A CHIRALPAK AGP column (0.4 x 10 cm, 5μm) was used with 10 mmol/L ammonium acetate (pH 5.5) and isopropanol (97:3) as the mobile phase. The detection wavelength was 324 nm, the flow rate was 1.0 mL/min, the column temperature was 25°C, and the injection volume was 5μL. The resolution between S-KT and R-KT was 2.8. S-KT and R-KT demonstrated a good linear relationship in the range of 3-60μg/mL (r > 0.999). The average recoveries of S-KT and RKT were 99.2% and 99.8%, with relative standard deviations of 2.0% and 2.4%, resp. The established method can be used for the resolution and determination of S-KT and R-KT.