摘要
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 dissolution determination of modafinil dispersible tablets.Method： A paddle method was adopted using water as the solvent,the rotation speed was 75 r·min-1,and an HPLC method was used to determine the content of modafinil.Result： The assay displayed a good linearity over the concentration range of 42.16~379.44 μg·ml-1（r=0.999 1）,and the average recovery was 99.6%（RSD=0.6%）.The mean cumulative dissolution of three batches of modafinil dispersible tablets was all above 90%.Conclusion： The method is rapid and accurate,and can be used in the quality control of modafinil dispersible tablets.
出处
《中国药师》
CAS
2012年第9期1289-1291,共3页
China Pharmacist
