Determination of Amidozon and Amantadine Hydrochloride in Compound Amantadine Hydrochloride Tablets by HPLC-ELSD / 中国药师

ABSTRACT

Objective: To establish a method for the determination of amidozon and amantadine hydrochloride in compound amantadine hydrochloride tablets by HPLC-ELSD.Methods: The analytical column was an Agilent Eclipse Plus C18 column (250 mm×4.6 mm, 5 μm).The mobile phase consisted of 0.1% trifluoroacetic acid solution-acetonitrile (85∶15) and the flow rate was 0.7 ml · min-1.The column temperature was room temperature.Both evaporation temperature and atomization temperature were 40 ℃.The flow rate of carrier gas (nitrogen) was 1.8 L · min-1 and the injection volume was 10 μl.Results: The peak area and logarithm of injection volume of ampicrine showed a good linear relationship within the range of 606.72-3 033.60 μg · ml-1 (r=0.999 7), and that of amantadine hydrochloride showed a good linear relationship within the range of 400.96-2 004.80 μg·ml-1 (r=0.999 4).The average recovery was 99.5% and 99.3%, and RSDs was 0.35% and 0.40%(n=9), respectively.Conclusion: The method is simple, rapid, accurate and reproducible, and suitable for the determination of aminopyrine and amantadine hydrochloride in compound amantadine aminopyrine tablets.