人血浆中阿加曲班浓度测定的方法学研究

目的建立血浆中阿加曲班药物浓度的高效液相色谱测定方法。方法血样中阿加曲班用有机溶剂（乙酸乙酯-异丙醇=4：1）提取浓缩后测定。色谱柱为Kromasil C18（4．6mm×250mm,5μm），流动相为乙腈-2％三乙胺溶液（45：55），检测波长为333nm。结果阿加曲班浓度在0．5～50μg·mL^-1呈良好线性关系（r=0．9995），最小可定量浓度为0．5μg·mL^-1，方法回收率为94．3％～102．4％（n=5），日内RSD为2．4％～7．8％（n=5）；日间RSD为3．7％～8．1％（n=15）。结论本方法简单、快速、准确、灵敏，可用于阿加曲班的血药浓度监测。

Methodology on determination of argatroban in human plasma

Objective To establish an RP-HPLC method for the determination of argatroban in human plasma. Methods Argatroban was extracted by organic solvent （EtAc ： isopropanol=4 ： 1） and determined. The separation was performed on Kromasil C18 column （4.6 mm× 250 mm, 5 μm）, and the mobile phase consisted of acetonitrile-2 % triethylamine （45 ： 55）. The detection wavelength was 333 nm. Results Argatroban was well separated from the internal standard and endogenous substance, and the regression curve （A= 0. 021C-0. 002, r^2 = 0. 999 2） was linear at 0. 5μg·mL^-1 - 50. 0μg·mL^-1, the quantitation limit was 0. 5μg·mL^-1. The method recoveries from the plasma were in at 94.3-102.4% （n=5）, while the intra-day and inter-day RSD were at 2.4-7.8% （n=5） and 3.7%- 8. 1% （n= 15）, respectively. Conclusion The method is simple, rapid , accurate and sensitive, and suitable for clinical laboratory monitoring of argatroban.