瑞舒伐他汀钙片的含量及溶出度测定

目的建立测定瑞舒伐他汀钙片含量和溶出度的方法。方法含量测定采用高效液相色谱（HPLC）法，色谱柱为Shim Pack CLC—ODS不锈钢柱（150mm×4．6mm，5μm），检测波长为242nm，流动相为0．03％枸橼酸溶液（三乙胺调pH至4．0）-乙腈（60：40）。溶出度测定采用紫外分光光度（UV）法，水作为溶出介质，检测波长为241nm。结果含量测定中，瑞舒伐他汀钙进样量在0．4—4．0μg范围内与峰面积线性关系良好（r=0．9998），平均回收率为99．78％，RSD=1．08％（n=9）；溶出度试验中，瑞舒伐他汀钙质量浓度线性范围为2．01．20-12μg／mL，溶出均一性良好。结论所用方法准确、简易，可作为瑞舒伐他汀钙片的含量和溶出度测定方法。

Content and Dissolution Rate Determination of Rosuvastatin Calcium Tablets

Objective To establish a determination method for the content of Rosuvastatin Calcium Tablets and dissolution rate. Methods The content determination was performed by HPLC, and accomplished on the Shimadzu C18 column （150mm×4.6mm,5μm）. The detection wavelength was at 242 nm. The mobile phase consisted of 0.03% citric acid solution （adjusted to pH 4.0 with triethanolamine）-acetonitrile （60：40）. The dissolution rate was measured by UV, and the detection wavelength was at 241 nm in water Results In assay, the good linear relationship was obtained over the range of 0.4-4. 0μg （ r = 0. 999 9）. The average recovery rate was 99. 78%,and RSD was 1.08% （n =9）. In the test of the dissolution rate, the linear relationship range was 2. 01-20. 12 μg/mL. The homogeneity was good, Conclusion The method is accurate and feasible for the measurement of the content and dissolution of Rosuvastatin Calcium Tablets.