甲磺酸酚妥拉明片溶出度测定方法的研究

Research about dissolution rate of Phentolamine Mesylate Tablets

目的 考察甲磺酸酚妥拉明片的体外释放行为,制订合理的溶出度测定条件。方法 以 10 0 0ml水为溶出介质,转速75r·min-1,间隔一定时间取样,采用UV法,于 2 78nm测定药物的溶出速率。结论 甲磺酸酚妥拉明在 8 0 32～ 4 0 16 μg·ml-1浓度范围内线性关系良好(r =1 0 0 0 0 ),平均回收率 10 0 3%,RSD =0 4 7% 结论 本品溶出迅速,主药在 2 0min内即可完全溶出,且均一性好。达到了很好的体外释放效果。

Objective To study the behavior of Phentolamine Mesylate Tablets in vitro, and determinate the condition of its dissolution rate. Methods Water (1000ml) was used as dissolution medium, with a rotation rate of 75 r·min -1. Samples were taken at a definite interval and Phentolamine was determined at 278nm by UV. Results The calibration curve of Phentolamine was linear in the range of 8.032～40.16μg·ml -1 (r=1.0000).The average recovery rate was 100.3% with RSD of 0.47%. Conclusion The tablets were dissolved rapidly, and active component could completely dissolved within 20min. Phentolamine Mesylate Tablets show an excellent dissolution behavior in vitro.