Determination of Genotoxic Impurities in Omarigliptin by HPLC

OBJECTIVE To establish an HPLC method to determine genotoxic impurities in omarigliptin bulk drug. METHODS The HPLC was carried out with Zorbax SB-C₁₈ column with the column temperature of 25℃. The injection volume was 20 μL. The mobile phase was 0.1% acetic acid water solutiom-acetonitrile (65:35) with the flow rate of 1 ml·min^-1. The detector was UVD with the detection wave of 220 nm. Acetonitrile was used as solvent for omarigliptin. RESULTS Isopropyl benzenesulfonate could be separated completely with good linear relationship in 4-60 μg·mL^-1. The average recovery of isopropyl benzenesulfonate was 98.56%(n=9, RSD=3.78%). CONCLUSION This method is simple, reproducible and accurate for determination of genotoxic impurities in omarigliptin bulk drug.