反相高效液相色谱法测定洛伐他汀有关物质  

RP-HPLC determination of the related substances of lovastatin

作　　者：姜建国[1] 张西如[1] 高燕霞[1] 郄冰冰[1] 

机构地区：[1]河北省药品检验所,石家庄050011

出　　处：《药物分析杂志》2009年第11期1956-1960,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立洛伐他汀有关物质的HPLC测定方法,同时考察了8个厂家13批洛伐他汀原料的有关物质。方法:使用Xterra C18柱(4.6 mm×250 mm,5μm),以乙腈-0.01%磷酸溶液(60∶40)为流动相梯度洗脱,流速为1.0 mL.min-1,检测波长为238 nm。结果:洛伐他汀色谱保留时间约为15min,与其有关物质分离良好,洛伐他汀的检测限为0.25 ng。结论:方法准确,灵敏度高,可有效地控制药品质量。Objective：To establish a method for determination of lovastatin by HPLC. And we inspected the related substances of thirteen batches of lovastatin. Method： A C18 column（Xterra ,4.6 mm ×250mm,5μm） was used. The mobile phase was acetonitrile -0.01% phosphoric acid （60：40,the method was linear elution ）, the speed was 1.0mL·min^-1,and the wavelength of UV detector was 238nm. Results： The retention time was about 15 minute , and the resolution of lovastatin with its related compounds was good . The limit of quantitation was 0.25ng . Conclusion： The method was convenient and accurate. As the same time , the method can intendance and control the related substance in production.

关 键 词：洛伐他汀 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]