高效液相色谱法测定依法韦仑异构体含量  

Determination of Isomer of Efavirenz by HPLC

作　　者：张稳稳 谭黎君 刘小东 郑曦孜 ZHANG Wenwen;TAN Lijun;LIU Xiaodong;ZHENG Xizi(College of Pharmacy,Chongqing Medical and Pharmaceutical College,Chongqing,China 401331;Chongqing Willway Pharmaceuticals Co.,Ltd.,Chongqing,China 400714;Changshou District Hospital of Traditional Medicine,Chongqing,China 401220)

机构地区：[1]重庆医药高等专科学校药学院,重庆401331 [2]重庆希韦医药科技有限公司,重庆400714 [3]重庆市长寿区中医院,重庆401220

出　　处：《中国药业》2023年第1期69-71,共3页China Pharmaceuticals

基　　金：重庆市教育委员会科学技术研究项目[KJQN201902801]。

摘　　要：目的建立测定依法韦仑异构体含量的高效液相色谱法。方法色谱柱为Agilent Zorbax SB-Phenyl苯基柱(250 mm×4.6 mm,5µm)和Chiralpak OD-H手性柱(250 mm×4.6 mm,5µm),流动相为正己烷-乙醇(97∶3,V/V),流速为1.0 mL/min,检测波长为250 nm,柱温为35℃,进样量为20µL。结果依法韦仑异构体的质量浓度在0.05~20.52µg/mL范围内与峰面积线性关系良好(r=0.9997,n=6);检测限为0.015µg/mL,定量限为0.050µg/mL;中间精密度试验和重复性试验结果的RSD均为5.22%(n=6);平均加样回收率为96.73%,RSD为1.50%(n=9)。3批样品中依法韦仑异构体的含量分别为0.11%,0.12%,0.11%。结论该方法可用于依法韦仑异构体的含量测定。Objective To establish the high-performance liquid chromatography(HPLC)method for the determination of the isomer of efavirenz.Methods The chromatographic columns were Agilent Zorbax SB-Phenyl column(250 mm×4.6 mm,5µm)and Chiralpak OD-H chiral column(250 mm×4.6 mm,5µm),the mobile phase was hexane-ethanol(97∶3,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 250 nm,the column temperature was 35℃,and the injection volume was 20µL.Results The linear range of isomer of efavirenz was 0.05-20.52µg/mL(r=0.9997,n=6).The limit of detection(LOD)was 0.015µg/mL,and the limit of quantitation(LOQ)was 0.050µg/mL.The RSD of intermediate precision test and repeatability test was 5.22%(n=6).The average recovery of isomer of efavirenz was 96.73%with an RSD of 1.50%(n=9).The contents of isomer of efavirenz in three batches of samples were 0.11%,0.12%and 0.11%respectively.Conclusion This method can be used for the determination of the isomer of efavirenz.

关 键 词：高效液相色谱法 依法韦仑 异构体 含量测定 

分 类 号：R927.2[医药卫生—药学] R979.5