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作 者:孙敏[1,2] 刘鹏[2] 付晓丽[2] 徐为人[1,2] 汤立达[2]
机构地区:[1]天津中医药大学,天津300193 [2]天津药物研究院天津市新药设计与发现重点实验室,天津300193
出 处:《中国新药杂志》2013年第10期1206-1209,1221,共5页Chinese Journal of New Drugs
基 金:国家"重大新药创制"科技重大专项(2011ZX09401-009;2010ZX09401-307-1-1)
摘 要:目的:建立大鼠血浆中测定达比加群的HPLC-UV法。方法:血浆蛋白用甲醇沉淀,采用Kro-masil C18柱(100 mm×4.6 mm,5μm);流动相为0.01 mol.L-1甲酸铵溶液-甲醇(77∶23);流速为0.5 mL.min-1。结果:血浆中达比加群检测方法的线性范围为0.05~20μg.mL-1;定量下限为0.05μg.mL-1;提取回收率为67.6%~71.3%;相对回收率为98%~109.7%;RSD小于10%。结论:本方法灵敏、准确、可靠,适用于大鼠血浆中达比加群的测定。Objective:To establish a HPLC-UV method for determination the concentration of dabigatran in rat plasma. Methods:The plasma proteins were precipitated by methanol. The separation was performed on a Kro- masil C 18 ( 100 mmμ 4.6 mm, 5 μm) analytical column using 0.01 tool- L - 1 ammonium formate-methanol ( 77: 23 ) as mobile phase at a flow rate of 0.5 mL· min-l. Results:The linear range of the plasma concentration of dabigatran was O. 05 - 20 μg · mL-1 and limit of detection was 0.05 μg· mL-l. The extractive recovery of dabigatran was 67.6% -71.3% ;the relative recovery of dabigatran was 98% -109.7%. The RSD was less than 10%. Conclu- sion:The method has high sensitivity and good selectivity and it can be used for the determination of dibagatran in rat plasma.
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