Determination of Related Substances in Lovastatin Tablet by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the determination of related substances in Lovastatin tablet. METHODS:HPLC was performed on the column of Waters XTerra? MS C18 with mobile phase A of 0.01%Phosphoric acid solution and B of acetonitrile(gradient elution)at a flow rate 1.0 ml/min,column temperature was 40 ℃,the detection wavelength was 238 nm,and the injection volume was 10 μl. RESULTS:The impurity components were well separated in principal components;the linear range of lovastatin was 17.5-700 μg/ml(r=0.9999);RSDs of precision,stability and reproducibility tests were lower than 1%;recov-ery was 99.30%-100.67%(RSD=0.4%,n=9). CONCLUSIONS:The method is reproducible with good durability and high preci-sion,and can be used for the quality control of Lovastatin tablet.