高效液相色谱法测定替诺福韦艾拉酚胺中的对映异构体  

Determination of Enantiomer in Tenofovir Alafenamide Fumarate by HPLC

作　　者：李昌亮 尚金凤 廖正华 蔡立荣 易必新 马晓宁 LI Chang-liang;SHANG Jin-feng;LIAO Zheng-hua;CAI Li-rong;YI Bi-xin;MA Xiao-ning(Hunan Institute for Drug Control,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China;Hinye Pharmaceutical Co.,Ltd.,Changsha 410331,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001 [2]药用辅料工程技术研究重点实验室,湖南长沙410001 [3]天地恒一制药股份有限公司,湖南长沙410331

出　　处：《海峡药学》2023年第1期37-40,共4页Strait Pharmaceutical Journal

基　　金：湖南省科技厅科药联合基金(2021JJ80032)。

摘　　要：目的建立高效液相色谱法测定替诺福韦艾拉酚胺中的对映异构体。方法用直链淀粉-三(3,5-二甲基苯基氨基甲酸酯)键合硅胶为填充剂(CHIRAL PAK AD-H,4.6 mm×250 mm,5μm或效能相当的色谱柱);以无水乙醇-甲醇-正庚烷-三乙胺(350∶50∶600∶1)为流动相等度洗脱;检测波长为260 nm;流速为0.4 mL·min^(-1);柱温:30℃。结果主成分峰与对映异构体峰的分离度均不小于1.5,对映异构体平均回收率为98.6%。结论该方法专属性强、灵敏度高、准确度和重复性好,方法简单、经济,可用于替诺福韦艾拉酚胺对映异构体的检查。OBJECTIVE To establish a HPLC method for the determination of enantiomer in Tenofovir alafenamide fumarate.METHODS CHIRAL PAK AD-H column(4.6 mm×250 mm,5μm)was used.The mobile phase was anhydrous ethanol-methanol-heptane-triethylamine(350∶50∶600∶1).The detection wavelength was 260 nm,the flow rate was 0.4 mL·min^(-1),and the column temperature was 30℃.RESULTS The main components and enantiomer were well separated(≥1.5),the average recovery of enantiomer was 98.6%.CONCLUSION The method is specific,accurate,sensitive,reliable,simple and economical,which is suitable for the determination of enantiomer in Tenofovir alafenamide fumarate.

关 键 词：替诺福韦艾拉酚胺 对映异构体 高效液相色谱法 

分 类 号：R927[医药卫生—药学]