Determination of related substances in tegoprazan by HPLC
Objective To determine the 3 related substances in tegoprazan by HPLC.Methods An Agilent Proshell 120 EC-C18(4.6 mm×100 mm,2.7 μm)column was used.The mobile phase A was 0.01 mol·L-1 ammonium acetate buffer,and the mobile phase B was acetonitrile,with linear gradient elution.The detection wavelength was 220 nm.The flow rate was 0.7 mL·min-1,and the column temperature was 40 ℃.The injection volume was 10 μL.Results The calibration curves of impurity A,B and C were 0.0972～1.944 μg·mL-1(r=0.9999),0.0509～1.018 μg·mL-1(r=0.9997),and 0.1089～2.178 μg·mL-1(r=0.9997).The average recovery was 96.27％,95.40％and 96.10％,with RSDs of 2.1％,2.3％and 2.2％.Conclusion The method is accurate and reliable,which can be used for the quality control of tegoprazan.
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