Determination of the Dissolution of Lovastatin Tablets / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for determination of the dissolution of lovastatin tablets and to investigate the dissolution of it from different manufactures.METHODS:HPLC was employed for content determination with Alltima C18 chromatographic column,and the mobile phase consisted of acetonitrile-0.01% phosphoric acid(60∶40)with the detective wavelength set at 238 nm.The dissolution was determined by paddle method with 2% sodium lauryl sulphate-phosphate buffered solution(pH 7.0)as medium at a rotation speed of 50 r?min-1,and the sampling time was 30 min.The dissolution rates of 12 batches of samples from 6 manufacturers were determined.RESULTS:The linear range of lovastatin was 4.88～195.2 ?g?mL-1(r=0.999 9)and its average recovery rate was 97.7%(RSD=1.3%,n=9).Of the 12 batches of samples,3 batches from 2 manufacturers had dissolution rates of less than 80%,and the other batches stood at 80%～101%.CONCLUSION:The method is accurate,reproducible and simple,and it is effective in the quality control of lovastatin tablets.