瑞舒伐他汀钙片对映异构体检测方法  

Research on the Enantiomer of Rosuvastatin Calcium Tablets

作　　者：徐慧娟 张晓燕 夏莉 王菲 XU Hui-juan;ZHANG Xiao-yan;XIA Li;WANG Fei(Hanhui Pharmaceuticals Company Limited,Zhejiang Hangzhou 310000,China;Heze Pharmaceuticals,Co.Ltd,Zhejiang Hangzhou 310018,China)

机构地区：[1]瀚晖制药有限公司,浙江杭州310020 [2]杭州和泽医药科技有限公司,浙江杭州318000

出　　处：《临床医药文献电子杂志》2020年第11期11-15,共5页Electronic Journal of Clinical Medical Literature

摘　　要：目的建立瑞舒伐他汀钙片对映异构体测定方法。方法为高效液相色谱法,色谱柱CHIRALCEL OJ-RH(4.6×150 mm,5μm),以0.1%(v/v)三氟醋酸水溶液-乙腈(75:25)为流动相,流速0.5 ml/min;波长:242 nm。结果在建立的色谱条件下,主成分、已知杂质与对映异构体分离度良好,对映异构体在浓度为0.2004~4.008μg/ml的浓度范围内线性良好,r为0.9999;对映异构体在各浓度下的平均回收率均在90%~110%之间,RSD小于10%(n=9)。结论本法简便、准确、可靠、灵敏,专属性强,可用于瑞舒伐他汀钙片对映异构体测定。Objective To establish a method for the enantiomer of Rosuvastatin Calcium Tablets.Methods HPLC analysis was performed on an CHIRALCEL OJ-RH(4.6mm×150mm,5μm),with a mobile phase of 0.01%(v/v)trifluoroacetic acid aqueous solution-acetonitrile(75:25)at a flow rate of 0.5 ml/min,the detection wavelength of which is 242 nm;Results The enantiomer of Rosuvastatin Calcium was completed separated from the main component and other known impurities.The enantiomer of Rosuvastatin Calcium showed good linearities in a range of 0.2004~4.008μg/ml(r=0.9999).The recoveries of the enantiomer of Rosuvastatin Calcium were 90%~110%,with RSDs<10%(n=9).Conclusions The method is sensitive and accurate for the enantiomer of Rosuvastatin Calcium tablets.

关 键 词：对映异构体 高效液相色谱法 瑞舒伐他汀钙 

分 类 号：R972[医药卫生—药品]