多非利特胶囊溶出度的测定方法

Dissolution test for Dofetilide Capsules

目的用HPLC法测定多非力特胶囊的溶出度。方法采用DiamonsilC18柱(4.6mm×250mm),流动相为磷酸盐缓冲液(pH7.0)-甲醇=55∶45,检测波长为231nm。按峰面积外标法计算。结果多非利特在0.125～2.25μg·ml-1范围内线性良好,线性方程为A=49330.69C+779.9751(r=0.9998,n=6),加样回收率为99.31%,RSD=1.0%。结论本方法简便、快速,结果准确、可靠,重现性好。

Objective To develop a HPLC method for the dissolution test of Dofetilide Capsules.Methods HPLC separation was carried out on a Diamonsil C_ 18 column(4.6mm×250mm),with phosphate buffer(pH7.0)∶methanol=55∶45 as mobile phase,using a UV detector and detective wave length was set at 231nm,and the external standard control was applied.Results A good linearity was demonstrated by linear equation A=49330.69C+779.9751(r=0.9998,n=6)of Dofetilide,and the average recovery was 99.31%(RSD=1.0%).Conclusion The method was accurate,sensitive and reliable.