HPLC测定依折麦布辛伐他汀片中6-氧代辛伐他汀含量

目的建立高效液相色谱法测定依折麦布辛伐他汀片中6-氧代辛伐他汀的含量。方法采用Phenomenex Luna Phenyl Hexyl柱(150×4.6mm,3μm),流动相A为0.025mol/L磷酸二氢钠溶液-乙腈(80:20),流动相B为乙腈,进行梯度洗脱,流速为1.5mL/min,检测波长为290nm,柱温为30℃,进样量为100μL。结果6-氧代辛伐他汀在0.02μg/mL~8μg/mL范围内与其峰面积成良好的线性关系(r=0.99998,n=6),平均回收率为98.27%,RSD为4%。结论该方法简便,准确,重复性好,可用于依折麦布辛伐他汀片中6-氧代辛伐他汀的质量控制。

Content Determination of 6-Oxo Simvastatin in Ezetimibe and Simvastatin Tablets by HPLC

Objective To establish a method for the content determination of 6-Oxo Simvastatin in Ezetimibe and simvastatin tablets by HPLC.Method Phenomenex Luna Phenyl Hexyl(150×4.6mm,3μm)column was used with mobile phase A consisted of 0.025mol/L Sodium dihydrogen phosphate solution-acetonitrile(80:20),and mobile phase B consisted of acetonitrile gradient elution at flow rate of 1.5 mL/min.The detection wavelength is 290nm,the column temperature is 30℃,and the injection volume is 100μL.Results The linear rang of 6-Oxo Simvastatin was 0.02μg/mL~8μg/mL(r=0.99998,n=6),the average recovery was 98.27%,and the RSD was 4%.Conclusion The method is simple,reliable,accurate and can be used in the quality control of 6-Oxo Simvastatin in Ezetimibe and simvastatin tablets.