瑞舒伐他汀钙胶囊溶出度测定的方法学研究

Methodological validation of dissolution of Rosuvastatin calcium Capsule

目的：验证瑞舒伐他汀钙胶囊溶出度的测定方法.方法：采用浆法,以水900ml为溶出介质,转速50转/分,用紫外分光光光度计在242nm波长处测定样品的吸光度.结果：瑞舒伐他汀钙在2.16～21.6ug/ml的浓度范围内与吸光度成良好的线性关系, r=1（n=6）,低中高3种浓度的平均回收率为在98.89%,RSD为0.63%.结论：本法能快速准确的测定瑞舒伐他汀钙胶囊的溶出度.

Objective:To Methodologically validate the detection of dissolution of Rosuvastatin calcium capsule.Methods:The dissolution of Rosuvastatin calcium capsule was detected by UV spectrophotometry, the 900 ml water as the solvent, the speed was 50 r/ min.Determination of the absorbance at the wavelength of 242 nm Result: The assay displayed a good liearity over the concentration rang of2.16~21.6ug/ml,r=1(n=6),the average recovery was 98.89% with RSD of 0.63% Conclusion:The method can rapidly and accurately detect Rosuvastatin Calcium Capsules dissolution.