Determination of Butyl Hydroxy Anisole in Simvastatin by HPLC

A method for analysis of butyl hydroxy anisole(BHA,antioxidant) in simvastatin had been established by HPLC.Separation and quantification of BHA was carried out on a C18 column(supelcosil C18 column,4.6 mm i.d.×150 mm,3μm) with a gradient elution of acetonitrile(mobile phase A) and phosphoric acid(0.1%,mobile phase B).The flow rate was 3.0 ml/min,and BHA was determined with UV detector at 292 nm.Gradient: 0～3 min 65 % B,3～3.5 min 65 %～45 % B,3.5～8.5 min 45 %～10 % B,8.5～9.5 min 10 % B,9.5～10 min 10 %～65 % B,10～11.9 min 65 % B,12 min stop.The experimental results showed a good separation of BHA with simvastatin and impurities.Good linear relationship between the peak area and the concentration of BHA was found with correlation coefficient(r) of 0.9998 within the range of 0.1～0.9 μg/mL.The detection limit of BHA was 0.4 ng and the method recovery was 99.3% with a relative standard deviation of 1.0%.The results showed that the method was simple,rapid and accurate for the determination of BHA in simvastatin.