Establishment and clinical application of ibrutinib blood concentration assay
- VernacularTitle:伊布替尼血药浓度检测方法的建立及临床应用
- Author:
Gongwei HAN
1
,
2
;
Teng ZHANG
1
;
Yingli ZHAO
3
;
Qinhua LIU
4
;
Quan XIA
1
Author Information
1. School of Pharmacy，Anhui Medical University，Hefei 230032，China
2. Dept. of Pharmacy，the First Affiliated Hospital of Anhui Medical University，Hefei 230022，China
3. Dept. of Pharmacy，the Second People’s Hospital of Hefei，Hefei 230012，China
4. Dept. of Hematology，the First Affiliated Hospital of Anhui Medical University，Hefei 230022，China
- Publication Type:Journal Article
- Keywords:
ibrutinib;
blood concentration;
non-Hodgkin’s lymphoma;
high performance liquid chromatography
- From:
China Pharmacy
2023;34(22):2756-2759
- CountryChina
- Language:Chinese
-
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.
