Determination of Residual Triethylamine in Tenofovir Disoproxil Fumarate by GC / 中国药师

ABSTRACT

Objective:To establish a method for the determination of residual triethylamine in tenofovir disoproxil fumarate. Methods:The residual treithylamine was determined by GC with an Agilent DB-624 capillary column(30 m × 0. 53 mm,3 μm)and an FID detector. The carrier gas was nitrogen and the flow rate was 2. 0 ml · min-1 . The oven temperature was programming in-creased. The initial column temperature was 50℃,and then raised to 220℃ at a rate of 10℃·min-1 ,and maintained 4 min. Trieth-ylamine was quantified by an external standard. Results:The calibration showed a good linearity within the range of 53. 02-742. 34 μg ·ml-1 for triethylamine. The correlation coefficient was 0. 999 8. The recoveries were within the range of 96. 52%-102. 27%. The relative standard deviation(RSD)was 2. 42%(n=9). Conclusion:The method has good specificity,repeatability and sensitivity, which can be used in determining the content of residual trietbylamine in tenofovir disoproxil fumarate.