摘要
目的建立阿托伐他汀钙软胶囊溶出度的测定方法.方法以磷酸盐缓冲液(pH7.4)900ml为溶出介质,采用转篮法(100r?min-1)45min取样,运用HPLC法对其溶出度进行测定,并考察了溶出曲线.结果样品溶出均一性良好,溶出度均>90%.结论本法能考察和控制阿托伐他汀钙软胶囊的质量.
OBJECTIVE A method was established about determining the dissolution of Atorvastatin Calcium Soft Capsules. METHODS The phosphate buffer solution(pH7. 4) was used as the dissolution medium and rotary basket method was also used(100r·min^-1) . The samples was determined after 45 mins. The dissolution content was determined by HPLC. The dissolution curve was discussed. RESULTS The dissolution homogeneity of three batches of samples was good and dissolution contents were all above 90 percent. CONCLUSION This method can control the quality of Atorvastatin Calcium Soft Capsules.
出处
《齐鲁药事》
2006年第12期737-739,共3页
qilu pharmaceutical affairs