Determination of the Related Substances in Edaravone and Sodium Chloride Injection by HPLC / 中国药师

ABSTRACT

Objective: To establish an HPLC method for the determination of the related substances in edaravone and sodium chlo-ride injection. Methods: The column was Kromasil C18(250 mm×4. 6 mm, 5 μm) at the temperature of 30℃. The mobile phase A for gradient elution was a solution containing 0. 2% acetic acid and 0. 2% trimethylamine, and methanol was used as the mobile phase B. The flow rate was 0. 8 ml·min-1, the detection wavelength was 244 nm, and the injection volume was 20 μl. Results: Under the described chromatographic conditions, edaravone was completely separated from its impurities. Edaravone and its impurities had good linear relationships within the range of 0.1 μg·ml-1-3 μg·ml-1(r >0.998). The average recoveries ranged from 90.0% to 110. 0% (RSD<10% , n=9), and the contents of their related substances were all below the limits (0. 3% ). Conclusion: The method is accurate, simple and convenient, which can be used for the determination of the related substances in edaravone and sodium chloride injection.