HPLC determination of EDAT-Na_2 in Propofol Injection

Objective:To establish an HPLC method for determination of EDAT-Na2 in propofol injection.Methods:Phenomenex Luna C18 column(100 mm×4.6 mm,5 μm)and gradient elution were used.Mobile phase A was 0.66% tetrabutylammonium hydroxide solution-acetonitrile(3∶1)(pH was adjusted to 7.0 by phosphoric acid),and mobile phase B is water-methanol(1∶9),the flow rate was 1.0 mL·min-1 and the detection wavelength was 260 nm.Results:The date showed that EDAT-Na2 in propofol injection could be detected excluding excipients interfering.Calibration curve was linear range of 20-80 μg·mL-1(r=0.9999),and the average recoveries of its high,middle and low concentrations were 100.7%,100.5% and 100.7%,respectively.Conclusions:This method is simple,accurate and reliable,so it can be used for quality control of EDAT-Na2.