高效液相色谱法测定瑞舒伐他汀钙片的含量

Content determination of Rosuvastatin Calcium Tablets by high performance liquid chromatography

目的：探讨高效液相色谱法测定瑞舒伐他汀钙片的含量的准确性。方法采用高效液相色谱法分别对三种批号的瑞舒伐他汀钙片进行测定，250 mm＆#215;4.6 mm，5μm色谱柱；流动相（46：54），0.2％三乙胺水溶液-乙腈，波长调至242 nm。结果瑞舒伐他汀钙片在浓度5.1～255μg/mL范围内，r＝0.9999，为良好线性关系。分别测得瑞舒伐他汀钙片含量为94.53%、95.76%、95.29%，RDS为0.59%、0.31%、0.11%。结论高效液相色谱法检测瑞舒伐他汀钙片含量，具有稳定性、准确性及重复性，值得推广应用。

Objective To investigate the accuracy of the content determination of Rosuvastatin by high performance liquid chromatography （HPLC）. Methods HPLC was used on three batches of Rosuvastatin Calcium Tablets. Results The concentration range Rosuvastatin Calcium Tablets was 5.1-255μg·mL-1,was a good linear relationship（r = 0.999 9）. Content of Rosuvastatin Calcium Tablets was 94.53%,95.76%,95.29%respectively,RDS was 0.59%,0.31%,0.11%respectively. Conclusion HPLC method for the determination of Rosuvastatin Calcium Tablets content has the stability,accuracy and repeatability,and is worthy of popularization and application.