RP-HPLC Determination of the Related Substances of Lovastatin and Its Tablets

OBJECTIVE To establish a method for determination of the related substances of lovastatin and its tablets by HPLC.And to inspect the related substances of thirteen batches of lovastatin and twelve batches of lovastatin tablets.METHODS An Xterra C18 column(4.6 mm×250 mm,5 μm)was used.The mobile phase was acetonitrile-0.01% phosphoric acid(60∶40,the method was linear elution),the speed was 1.0 mL·min-1,and the wavelength of UV detector was 238 nm.RESULTS The retention time was about 15 min,and the resolution of lovastatin with its related compounds was good.The limit of quantitation was 0.25 ng.CONCLUSION The method was convenient and accurate.As the same time,the method can intendance and control the related substance in production.