伊布替尼血药浓度检测方法的建立及临床应用
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篇名: 伊布替尼血药浓度检测方法的建立及临床应用
TITLE: Establishment and clinical application of ibrutinib blood concentration assay
摘要: 目的 建立检测伊布替尼血药浓度的方法并应用于临床。方法以泽布替尼为内标,血浆样本以固相萃取柱处理后,采用高效液相色谱(HPLC)法检测伊布替尼的浓度。以Agilent5TC-C18(2)为色谱柱,乙腈-0.5%磷酸二氢钾溶液(43∶57,V/V)为流动相,流速为1mL/min,检测波长为260nm,柱温为40℃,进样量为20μL,运行时间为25min。采用上述方法测定9例非霍奇金淋巴瘤患者第30天用药后2h时血浆中伊布替尼的浓度。结果伊布替尼检测质量浓度的线性范围为10~500ng/mL(R2=0.9989),定量下限为10ng/mL;批内、批间精密度试验的RSD均不高于12.77%;提取回收率分别为74.80%、97.70%,RSD均小于2.90%;稳定性试验的RSD均小于7.10%。9例患者的血药浓度为15.341~279.628ng/mL。结论所建立的HPLC法简单、快捷,可用于伊布替尼血药浓度的测定。
ABSTRACT: OBJECTIVE To establish a method to detect the blood concentration of ibrutinib and apply it to the clinic. METHODS Using zanubrutinib as internal standard, the concentration of ibrutinib was detected by high performance liquid chromatography (HPLC) after plasma samples were processed by solid-phase extraction. The separation was performed on an Agilent 5 TC-C18(2) column with acetonitrile-0.5% potassium dihydrogen phosphate solution (43∶57, V/V) as the mobile phase at a flow rate of 1 mL/min, a detection wavelength of 260 nm, a column temperature of 40 ℃ , a sample size of 20 μL, and a run time of 25 min. The concentration of ibrutinib was measured in the plasma of 9 patients with non-Hodgkin’s lymphoma 2 h after drug administration on the 30th day by the above method. RESULTS The linear range of the assayed mass concentration of ibrutinib was 10-500 ng/mL (R 2=0.998 9), the lower limit of quantification was 10 ng/mL, and the RSDs of the intra-batch and inter-batch precision tests were not higher than 12.77%. The recoveries of the extraction were 74.80% and 97.70%, with both RSDs<2.90%, and the RSDs of the stability tests were not higher than 7.10%. The peak plasma concentrations of 9 patients were 15.341-279.628 ng/mL. CONCLUSIONS The established HPLC method is simple and rapid, and can be used for the determination of ibrutinib concentration in plasma samples.
期刊: 2023年第34卷第22期
作者: 韩功伟;张腾;赵营莉;刘沁华;夏泉
AUTHORS: HAN Gongwei,ZHANG Teng,ZHAO Yingli,LIU Qinhua,XIA Quan
关键字: 伊布替尼;血药浓度;非霍奇金淋巴瘤;高效液相色谱法
KEYWORDS: ibrutinib; blood concentration; non-Hodgkin’s lymphoma; high performance liquid chromatography
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