Determination of Content and the Related Substances of Simvastatin Tablets by HPLC

OBJECTIVE To establish a method for determining the content and related substances of simvastatin tablets.METHODS The separation was carried out on a SUPELCO C18 column (3 μm,4.6 mm×33 mm) with gradient elution.The mobile phase consisted of acetonitrile-0.1% phosphoric acid solution (50:50) as the mobile phase A,and 0.1% phosphoric acid in acetonitrile as the mobile phase B.The flow rate was at 3.0 mL·min-1and the detection wavelength was at 238 nm.RESULTS The resolution between the peak of losvatatin and simvastatin was above 5.0.The linear range of the method was 21.88-196.9 μg·mL-1 and the regression equation was A=65 929ρ+4 676 (r=0.999 6,n=7).The average recovery was 99.55%(RSD=0.67%,n=9) and the limit of detection was 25.14 ng·mL-1.The sample solution was stable within 3 h.CONCLUSION The method is specific,accurate,sensitive and can be used for the determination of content and related substances of simvastatin tablets.