Determination of EDTA-2Na in Acetylcysteine Solution by HPLC

OBJECTIVE To establish an HPLC method for determination of the content of EDTA-2Na in acetylcysteine solution. METHODS ACE Excel 2 AQ column(150 mm×2.1 mm, 2 µm) was used with the column temperature of 40℃. The mobile phase A was 0.4% phosphoric acid, the mobile phase B was 0.4% phosphoric acid methanol solution, and the gradient elution was used. The flow rate was 0.2 mL·min^-1. The detector wavelength was 205 nm. RESULTS EDTA-2Na had a good linearity in the range of 5-25 μg·mL^-1(r=0.999 9), the average recovery of the 3 concentrations was >99%, and the RSD was ≤ 0.5%, EDTA-2Na and the other components in the solution could be separated effectively(the resolution was >2). CONCLUSION The method does not require derivation, it is simple, rapid and accurate, which can be used for the determination of the content of EDTA-2Na in acetylcysteine solution.