中国药房2016，Vol.27Issue(12)：1683-1685,3.DOI:10.6039/j.issn.1001-0408.2016.12.33
HPLC法测定洛伐他汀分散片中的有关物质
Determination of Related Substances in Lovastatin Tablet by HPLC
孙婷 1杨浩天 2刘红莉 1盖宾杰 1耿韫 1盖成1
作者信息
- 1. 河北省药品检验研究院,石家庄 050011
- 2. 河北医科大学药物分析教研室,石家庄 050017
- 折叠
摘要
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.关键词
高效液相色谱法/洛伐他汀分散片/有关物质Key words
HPLC/Lovastatin dispersible tablet/Related substance分类
医药卫生引用本文复制引用
孙婷,杨浩天,刘红莉,盖宾杰,耿韫,盖成..HPLC法测定洛伐他汀分散片中的有关物质[J].中国药房,2016,27(12):1683-1685,3.
