论文部分内容阅读
目的:建立莫达非尼分散片的溶出度测定方法。方法:采用桨法,水为溶出介质,转速75 r.min-1,15 min取样,采用高效液相色谱法测定莫达非尼的溶出量。结果:莫达非尼在42.16～379.44μg.ml-1浓度范围内呈良好的线性关系(r=0.999 1),平均回收率为99.6%(RSD=0.6%)。3批样品在15 min时的溶出度均超过标示量的90%。结论:该方法快速准确,可作为莫达非尼分散片的质量控制方法之一。
Objective: To establish a method for the determination of dissolution of modafinil dispersible tablets. Methods: The paddle method and water as dissolution medium were used. The sample was taken at 75 rpm for 15 min. The dissolution rate of modafinil was determined by high performance liquid chromatography. RESULTS: Modafinil had a good linear relationship (r = 0.999 1) with an average recovery of 99.6% (RSD = 0.6%) at a concentration range of 42.16 to 379.44 μg.ml-1. Three batches of samples at 15 min when the dissolution rate of more than 90% of the labeled amount. Conclusion: The method is rapid and accurate and can be used as one of the quality control methods for modafinil dispersible tablets.