依折麦布片有关物质的HPLC法测定  

Determination of the Related Substances in Ezetimibe Tablets by HPLC

作　　者：刘清梁 赵丕华 杨琰 王文峰 

机构地区：[1]华润赛科药业有限责任公司研发中心,北京100111

出　　处：《中国医药工业杂志》2016年第12期1573-1577,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法测定依折麦布片的有关物质。采用Hypersil Gold C8色谱柱,以甲醇∶0.05%三氟乙酸溶液（50∶50）为流动相,检测波长232 nm。依折麦布与其非对映异构体[6,（3R,4S）-1-（4-氟苯基）-3-[（3R）-3-（4-氟苯基）-3-羟基丙基]-4-（4-羟基苯基）-2-氮杂环丁酮]的分离度为1.8;依折麦布及其有关物质2、非对映异构体和有关物质3分别在12~820、9.6~640、12~780和12~780 ng/ml范围内线性关系良好。上述有关物质的相对校正因子分别为0.8、1.0和1.2;平均回收率分别为102.5%、104.4%和97.9%,RSD分别为1.3%、1.7%和2.4%。An HPLC method was established for the determination of related substances in ezetimibe （1） tablets. A Hypersil Gold C8 column was used, with the mobile phase of methanol∶0.05% TFA （50∶50）, at the detection wavelength of 232 nm. The resolution between 1 and its diastereoisomer [6, （3R,4S）-1-（4-fluorophenyl）-3-[（3R）-3-（4-fluorophenyl）-3-hydroxypropyl]-4-（4-hydroxyphenyl）azetidin-2-one] was 1.8. It was linear for 1, the related substance 2, diastereoisomer 6 and the related substance 3 in the ranges of 12—820, 9.6—640, 12—780 and 12—780 ng/ml, respectively. Their relative correction factors were 0.8, 1.0 and 1.2. Their average recoveries were 102.5%, 104.4% and 97.9%, with RSDs of 1.3%, 1.7% and 2.4%, respectively.

关 键 词：依折麦布 有关物质 高效液相色谱法 含量测定 

分 类 号：O657.72[理学—分析化学] TQ460.72[理学—化学]