RESUMEN
Objective To establish an HPLC method for the determination of anti-influenza drug GZ830 and its related substances, and investigate the degradation of GZ830. Methods The degradation of GZ830 under the conditions with different pH and temperatures was investigated with HPLC method to explore the degradation principle. Results The HPLC method for the determination of GZ830 was established. The linear relationship between the drug and the peak area was good in the concentration range of 160-1200 μg/ml (r=0.9998). GZ830 was easily degraded under alkaline conditions and could not tolerate high temperatures. The degradation of GZ80 did not occur when its aqueous solution was kept at 40℃ for 6 h. However, after heating at 80℃ for 6 h, about 2.4％GZ80 was degraded and the degradation rate reached about 7％ after kept at 115℃ for 30 min. Conclusion Under the optimized chromatographic conditions, GZ830 was well separated from the degraded products, and the HPLC method possessed high sensitivity and good specificity for the determination of GZ80, and the degradation of GZ80 was different under different conditions.