Verification of the Method for the Content Determination of Simvastatin Tablets by HPLC
QU Feng-ping · Zhongguo yaofang · 2013
OBJECTIVE:To confirm the reliability of the method for the content determination of Simvastatin tablets stated in Chinese Pharmacopeia,which is good for popularization and application.METHODS:HPLC method was adopted.The separation was performed on Ultimate XB-C 18 column with mobile phase consisted of acetonitrile-0.025 mol/L NaH 2 PO 4(pH 4.5,65:35,V/V) at the flow rate of 1.0 ml/min.The detection wavelength was set at 238 nm and the injection volume was 20 μl.RESULTS:Under this chromatographic condition,simvastatin was well-separated from impurity and got a good peak profile.The linear range of simvastatin was 24.97-174.8 μg/ml(r=0.999 9)with an average recovery of 99.7%(RSD=0.92%,n=9).The repeatability,intermediate precision,stability and sample determination can meet demand.CONCLUSION:The method stated in Chinese Pharmacopeia is specific,accurate,stable,reliable and applicable,and it is worthy of spreading in the clinic.