阿托伐他汀钙胶囊溶出度测定方法的研究

Study on the Dissolution of Determination Method for Atorvastatin Calcium Capsules

目的:建立阿托伐他汀钙胶囊溶出度测定方法。方法:用水为溶剂介质,以HPLC法测定溶出度。结果:阿托伐他汀钙的线性范围为0.07～0.35μg(r=0.9999);平均回收率99.5%,RSD 1.0%。结论:本方法适用于阿托伐他汀钙胶囊的溶出度测定。

Objective： To establish a dissolution of determination method for Atorvastatin calcium capsules. Method： The dissolution rate were determined by an HPLC method, using the water as dissolution medium. Result： The linear range of atorvastatin calcium was 0.07 -0.35 μg（ r =0.999 9 ）. The average recovery was 99.5% with RSD 1.0%, Conclusion： The method can be used for dissolution test of atorvastatin calcium capsules.