高效液相色谱法测定大鼠血浆中来那度胺的浓度及其药动学(英文)

Study on HPLC Determination and Pharmacokinetics of Lenalidomide in Rat Plasma

目的:建立高效液相色谱法测定大鼠血浆中来那度胺的浓度。方法:色谱柱采用VenusilASBC18column(4.6 mm×250mm,5μm)购自于博纳艾杰尔科技有限公司。样品采用梯度洗脱,流动相为乙腈和0.05%甲酸溶液,流速为1.0 mL/min,检测波长为254 nm,以沙利度胺为内标。结果:来那度胺血药浓度的线性范围为0.1-5μg/mL,最低检测限为0.1μg/mL,三个浓度的QC样品(0.2,1 and 5μg/mL)的提取回收率分别为78.8±3.8,80.1±3.2 and 79.1±7.6%。结论:此方法准确、简便、灵敏度高,对来那度胺的血药浓度测定和药物代谢动力学研究极具价值。

Objective： To set up a HPLC method for the determination of lenalidomide in rat plasma. Methods： The analytical column was a Venusil ASB C18 column （4.6 mm×250mm,5μm） from Agela Technologies. Separation was achieved by gradient elution using acetonitrile-water containing 0.05 % formic acid, with the flow rate of 1 mL/min. The UV detection wavelength was 254 nm. Thalidomide was used as the internal standard. Results： The lower limit of quantification （LLOQ） of the method was 0.1μLg/mL and the linear range was 0.1-5.0 μg/mL. The extraction recovery of lenalidomide was 78.8 ± 3.8, 80.1 ± 3.2 and 79.1 ± 7.6 % at concentrations of 0.2, 1.0 and 5.0 μg/mL （QC samples）, respectively. Conclusion： The method is accurate and simple with the high sensitivity and will be valuable for the determination of lenalidomide plasma concentrations and the pharmacokinetic study.