正相高效液相色谱法同时测定瑞舒伐他汀叔丁酯中的对映异构体和非对映异构体  

Simultaneous Determination of the Enantiomer and Diastereomers in tert-Butyl Rosuvastatin by Normal Phase High Performance Liquid Chromatography

作　　者：曲喜龙 李铁健 刘治军 魏瑞霞 张贵民 QU Xilong;LI Tiejian;LIU Zhijun;WEI Ruixia;ZHANG Guimin(National Chiral Pharmaceutical Engineering and Technology Research Center,Lunan Pharmaceutical Group Co.,Ltd.,Linyi 276006;Shandong New Time Pharmaceutical Co.,Ltd.,Linyi 273400)

机构地区：[1]鲁南制药集团股份有限公司,国家手性制药工程技术研究中心,山东临沂276006 [2]山东新时代药业有限公司,山东临沂273400

出　　处：《中国医药工业杂志》2022年第5期698-702,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了正相高效液相色谱法同时测定瑞舒伐他汀叔丁酯(1)中的对映异构体(2)和非对映异构体Ⅰ、Ⅱ(3、4)。采用Daicel CHIRALPAK■ AD-H手性色谱柱(4.6 mm×250 mm,5μm),以正己烷∶正丙醇(90∶10)为流动相,等度洗脱,紫外检测波长为242 nm,流速为1.0 ml/min,柱温为25℃。结果显示,建立的方法专属性良好,1~4分别在相应浓度范围内线性关系良好;2、3、4的平均回收率(n=9)分别为97.2%、96.5%、97.6%,RSD分别为4.1%、3.6%、3.1%。建立的方法操作简便、灵敏度高,可用于1中对映异构体和非对映异构体含量的检测。A normal phase high performance liquid chromatography was established for the simultaneous determination of the enantiomer(2)and the diastereomersⅠandⅡ(3 and 4)in tert-butyl rosuvastatin(1).A Daicel CHIRALPAK■ AD-H chiral column(4.6 mm×250 mm,5μm)was adopted with n-hexane∶n-propanol(90∶10)as the mobile phase(isocratic elution).The UV detection wavelength was 242 nm,the flow rate was 1.0 ml/min,and the column temperature was 25℃.The results showed that the established method had good specificity,and it was linear for 1-4 in the corresponding concentration ranges.The average recoveries(n=9)of 2,3,and 4 were 97.2%,96.5%and 97.6%with the RSDs of 4.1%,3.6%and 3.1%,respectively.The established method is simple and sensitive,which can be used for the detection of the enantiomer and diastereomers in 1.

关 键 词：瑞舒伐他汀叔丁酯 正相高效液相色谱法 对映异构体 非对映异构体 

分 类 号：O657.72[理学—分析化学] R917[理学—化学]