High-throughput salting-out assisted liquid-liquid extraction using a 3D printed device and its application in the quantification of ibrutinib and its metabolite PCI-45227 in human serum

Écsiová, Dominika; Šimkovič, Martin; Uher, Martin; Hroch, Miloš

doi:10.1016/j.jpba.2022.114923

Cited by 7 publications

(2 citation statements)

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“…Therefore, there is a necessity to develop an analytical method to study the relationship between plasma exposure and the clinical response of BTK inhibitors in patients, especially when combined with antifungals. To date, several articles have focused on the determination of IBR in human plasma or whole blood by LC-MS/MS [ 16 , 17 , 18 , 19 , 20 , 21 ]. Four studies [ 16 , 17 , 18 , 19 ] did not quantify the active metabolite, dihydroxydiol ibrutinib (DIH).…”

Section: Introductionmentioning

confidence: 99%

“…To date, several articles have focused on the determination of IBR in human plasma or whole blood by LC-MS/MS [ 16 , 17 , 18 , 19 , 20 , 21 ]. Four studies [ 16 , 17 , 18 , 19 ] did not quantify the active metabolite, dihydroxydiol ibrutinib (DIH). The methods developed by Mukai et al [ 20 ] and Koller et al [ 21 ] involved a liquid/solid extraction step, which complicated the sample preparation procedure.…”

Section: Introductionmentioning

confidence: 99%

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Simultaneous Determination of Orelabrutinib, Zanubrutinib, Ibrutinib and Its Active Metabolite in Human Plasma Using LC-MS/MS

et al. 2023

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Ibrutinib, orelabrutinib, and zanubrutinib are all Bruton’s tyrosine kinase inhibitors, which have greatly improved the treatment of B-cell malignancies. In this study, an LC-MS/MS method was developed and validated for the determination of orelabrutinib, zanubrutinib, ibrutinib, and its active metabolite dihydrodiol ibrutinib in human plasma. The Ibrutinib-d5 was used as the internal standard. Pretreatment was performed using a simple protein precipitation step using acetonitrile. The ACQUITY UPLC HSS T3 column (2.1×50 mm, 1.8 μm) was used to separate the analytes, and the run time was 6.5 min. The mobile phase consisted of acetonitrile and 10 mM of ammonium formate, which contained 0.1% formic acid. The multiple reactions’ monitoring transitions were selected at m/z 428.1→411.2, 472.2→455.2, 441.1→304.2, 475.2→304.2 and 446.2→309.2 respectively for orelabrutinib, zanubrutinib, ibrutinib, dihydrodiol ibrutinib and ibrutinib-d5 using positive ion electrospray ionization. The standard curves were linear, from 0.400 to 200 ng/mL for ibrutinib and dihydrodiol ibrutinib, 1.00–500 ng/mL for orelabrutinib, and 2.00–1000 ng/mL for zanubrutinib. Selectivity, the lower limit of quantitation, precision, accuracy, matrix effect, recovery, stability, and dilution integrity all met the acceptance criteria of FDA guidance. This method was used to quantify the plasma levels of orelabrutinib, zanubrutinib, ibrutinib, and dihydrodiol ibrutinib in clinical patients.

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