HAN Gongwei,ZHANG Teng,ZHAO Yingli,et al.Establishment and clinical application of ibrutinib blood concentration assay[J].ZHONGGUO YAOFANG,2023,34(22):2756-2759.
To establish a method to detect the blood concentration of ibrutinib and apply it to the clinic.
METHODS
2
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-C
18
(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
2
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
2
The established HPLC method is simple and rapid, and can be used for the determination of ibrutinib concentration in plasma samples.
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Establishment of HPLC fingerprints for Ardisia crenata, Sophora tonkinensis and their couplet medicines and content determination of 5 chemical components
Study on tissue distribution of curcumin solid lipid nanoparticles in rats
Study on the improvement of quality standard for Jubei mixture
淫桂通便颗粒的质量标准研究
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