高效液相色谱法测定比伐卢定中三氟乙酸含量

Determination of trifluoroacetic acid in bivalirudin by HPLC

目的建立高效液相色谱法测定比伐卢定中三氟乙酸的含量。方法色谱柱:Kromasil100-5C18柱(4.6mm×200mm,5μm),流动相:0.07%磷酸溶液(pH3.0)-甲醇(98∶2),流速:1.0mL/min,柱温:30℃,检测波长:210nm,进样量:20μL。结果三氟乙酸浓度在198.4～992.0μg/mL范围内,线性关系良好,r=0.9999;检测限为40ng;加样回收率平均为99.9%,RSD为0.41%。结论此法可用于比伐卢定中三氟乙酸含量的测定,准确度高。

Purpose To establish a HPLC method for determination of the content of trifluoroacetic acid in bivalirudin.Methods Kromasil 100-5 C18 column（4.6 mm×200 mm,5 μm） and 0.07% phosphoric acid solution（pH 3.0）-methanol（98：2）as the mobile phase at a flow rate of 1.0 mL/min were used with a column temperature of 30 ℃,a detection wavelength of 210 nm and a injection volume of 20 μL.Results The standard curve of trifluoroacetic acid was linear in the range of 198.4-992.0 μg/mL,r=0.999 9.The detection limit was 40 ng.The average recovery rate of method was 99.9%,and RSD was 0.41%.Conclusion The method of content determination was practicable and accurate.It can be used for content determination of trifluoroacetic acid in bivalirudin.