GC法测定恩替卡韦中的苯甲醇和氯化苄  

Determination of benzyl alcohol and benzyl chloride in Entecavir by GC

作　　者：王娜娜[1,2] 张道林 蒋心惠[1] WANG Nana;ZHANG Daolin;JIANG Xinhui(Pharmacy School of Chongqing Medical University,Chongqing,400016 P.R.China;Luohe third People’s Hospital of Henan Province,Luohe,Henan,462000 P.R.China;Chongqing Institute of Pharmaceutical Industry,Chongqing,400061 P.R.China)

机构地区：[1]重庆医科大学药学院,重庆400016 [2]漯河市第三人民医院,河南漯河462000 [3]重庆医药工业研究院有限责任公司,重庆400061

出　　处：《华西药学杂志》2022年第2期203-205,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用GC法测定恩替卡韦中的苯甲醇和氯化苄。方法采用毛细管GC法,色谱柱为HP-5(30 m×0.32 mm,0.25μm),载气为氮气,流速1.0 mL·min^(-1),柱温115℃,保持6 min,检测器温度300℃,样口温度260℃,分流比3:1,手动进样,以外标法计算含量。结果26.72~106.9μg·mL^(-1)苯甲醇与峰面积的线性关系良好(r=0.9979);加样回收率为101.2%,RSD=2.96%(n=6);25.28~101.1μg·mL^(-1)氯化苄与峰面积的线性关系良好(r=0.9995);加样回收率为101.8%,RSD=1.88%(n=6)。结论所用方法准确、重复性好,可为恩替卡韦的质量标准研究提供参考。OBJECTIVE To establish the method of determination for benzyl alcohol and benzyl chloride in Entecavir by GC.METHODS All separations were achieved on an HP-5(30 m×0.32 mm,0.25μm)column.The carrier gas flow rate(nitrogen)and 1.0 mL·min^(-1) while the split ratio was 3:1.The column temperature was 115℃and constant in 6 minutes,the detector temperature was 300℃and the inlet temperature was 260℃at the same time.The injection modes were manual injection.The content of benzyl alcohol and benzyl chloride were calculated by the external standard method.RESULTS Benzyl alcohol showed good linearity in the concentration range of 26.72-106.9μg·mL^(-1)(r=0.9979)with the average recovery rate of 101.2%and RSD of 2.96%(n=6).Benzyl chloride showed good linearity in the concentration range of 25.28-101.1μg·mL^(-1)(r=0.9979),with the average recovery rate of 101.8%and with an RSD of 1.88%(n=6).CONCLUSION The method is accurate and reproducible.It can be used for quality control of the residual solvents in Entecavir.

关 键 词：恩替卡韦 气相色谱法 苯甲醇 氯化苄 含量测定 准确性 重复性 

分 类 号：R917[医药卫生—药物分析学]