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目的对罗氟司特片的含量与均匀度进行测定。方法对照组色谱柱为C18,其流动相速度控制在1 ml/1 min,色谱柱的温度保持在25℃左右,进样量为20μl;观察组色谱柱为C18,其流动相速度控制在1 ml/1 min,色谱柱的温度保持在10℃左右,进样量为20μl。观察2组在专属性、线性关系是否呈良好趋势、精密度、稳定性、回收率的测定等方面的情况。结果观察组在线性关系、精密度、稳定性、回收率以及测定结果方面均要优于对照组(P<0.05)。结论利用观察组的测定方式测定罗氟司特的含量均度稳定性和准确率高,值得推广应用。
Objective To determine the content and evenness of roflumilate tablets. Methods The control column consisted of C18 with a mobile phase velocity of 1 ml / 1 min. The temperature of the column was kept at about 25 ℃. The injection volume was 20μl. The observation column consisted of C18 with a mobile phase velocity of 1 ml / 1 min, the temperature of the column is kept at about 10 ℃, the injection volume is 20μl. Observe the two groups in the specificity, the linear relationship is good trend, precision, stability, recovery rate determination and so on. Results The observation group was better than the control group in terms of linearity, precision, stability, recovery rate and measurement results (P <0.05). Conclusion The determination of roflumilast in the observation group is more stable and accurate, and it is worth to be popularized.