Determination of simvastatin and its related substances in simvastatin tablets by HPLC / 中国基层医药

ABSTRACT

Objective To establish an HPLC method for determination of simvastatin and its related substances.Methods The HPLC system consisted Luna C18 column(250mm×4.6mm,5μm),the mobile phase was 0.025mol/L sodium phosphate monobasic(pH 4.5)acetonitrile(3565).The flow rate wns 1.0ml/min,and with detection 238nm.The column temperature was room temperature;injeetion volume WaS 20μl.Results SimvaStatin and its related substances can be completely separated by the method with a linear range of 2～200μg/ml.Calibration culwe was linear over the range of Y=3.256C×103+4.510×102(r=0.9996);for potency assay the mean recovery rate was 99.32% with RSD as 0.31%(n=9).Conclusion The method has good reproducibility,high accuracy and strong specificity.It was suitable for determination of simvastatin and its related substances.