Determination of the Related Substances of 4-Demethoxydaunorubicin by HPLC
Objective:To establish a HPLC method for the determination of the related substances of 4-demethoxydaunoru-bicin. Methods:A Welch Ultimate AQ-C18 (250 mm×4.6 mm,5 μm) column was selected for the separation of impurities. 0.1% Phosphoric acid solution was used as the mobile phase A,and the mobile phase B was consisted of methanol-acetonitrile (50∶50). The flow rate was 1.0 mL·min-1,and the detection wavelength was 254 nm,and the column tempera-ture was 35℃. Results:The chief peak and every impurity peak were separated well. A good linearity for 4-demethoxydau-norubicin was obtained over the range of 0.15~2.45 μg·mL-1 (r=0.9999),and the LOD was 0.021 μg·mL-1. Conclusion:The method is sensitive,accurate,and suitable for quality control of 4-demethoxydaunorubicin.