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目的:建立富马酸替诺福韦二吡呋酯中三乙胺残留的检测方法。方法:采用气相色谱法,色谱柱为安捷伦DB-624毛细管柱(30 m×0.53 mm,3μm),氢火焰离子化检测器(FID),载气为氮气,流速2.0 ml·min-1,柱温采用程序升温,初始温度为50℃,以10℃·min-1升温至220℃,保持4 min,采用外标法定量。结果:三乙胺浓度在53.02~742.34μg·ml-1的范围内,峰面积和浓度呈现良好的线性关系,相关系数为0.999 8;回收率为96.52%~102.27%,RSD为2.42%(n=9)。结论:本法专属性强、重复性好、灵敏度高,可用于富马酸替诺福韦二吡呋酯中三乙胺残留测定。
Objective: To establish a method for the determination of triethylamine in tenofovir disoproxil fumarate residue. Methods: The column was Agilent DB-624 capillary column (30 m × 0.53 mm, 3 μm) and hydrogen flame ionization detector (FID). The carrier gas was nitrogen and the flow rate was 2.0 ml · min-1. Temperature program temperature, the initial temperature of 50 ℃, 10 ℃ · min-1 temperature to 220 ℃, hold 4 min, the use of external standard method. Results: The concentration of triethylamine in the range of 53.02 ~ 742.34μg · ml-1, the peak area and concentration showed a good linear relationship, the correlation coefficient was 0.999 8; recovery was 96.52% ~ 102.27%, RSD was 2.42% (n = 9). Conclusion: This method is specific, reproducible and sensitive. It can be used for the determination of triethylamine in tenofovir disoproxil fumarate residue.