The Effect of Yinchenhao Decoction on the Pharmacokinetic Profile of Futibatinib by HPLC-MS/MS

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS

ACS Applied Bio Materials Pub Date : 2024-07-11 DOI:10.3390/separations11070213

Chunfu Wang, Songmao Liang, Jiachen Xu, Yingfan Zhai, Jianghui Chen, Xiangjun Qiu

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引用次数: 0

Abstract

Futibatinib is an excellent fibroblast growth factor receptor 1–4 (FGFR 1–4) inhibitor that exhibits selective anti-tumor activeness against FGFR-deregulated tumors. A new high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) technique for the quantitative analysis of futibatinib in beagle dog plasma was developed, and the effect of Yinchenhao decoction (YCHD) on the pharmacokinetics of futibatinib was evaluated. After processing plasma samples with ethyl acetate extraction in the alkaline condition of sodium carbonate, a C18 column (4.6 mm × 150, 5 μm) was used to accomplish the separation of futibatinib and ripretinib (internal standard, ISTD), with the mobile phase consisting of methanol and 0.1% formic acid in water (60:40). The scanning method adopted a multiple reaction monitoring (MRM) mode with positive ion detection through the triple quadrupole mass spectrometer. The ion transitions for futibatinib and IS were m/z 419.20 → 296.15 and m/z 510.36 → 417.00, respectively. Futibatinib displayed excellent linearity in the range of 1–200 ng/mL. Neither inter-day nor intra-day precision exceeded 6.3%. The %RE values for accuracy ranged from −3.1% to 0.9%. The recovery, stability, and matrix effect of futibatinib also complied with the guidelines for the validation of quantitative analysis methods for biological samples in the 2020 edition of the Chinese Pharmacopoeia. In combination with YCHD, the Cmax of futibatinib increased by 40.84% compared to futibatinib dosage alone., and the AUC(0–t) and AUC(0–∞) of futibatinib increased by 78.06% and 82.71%, respectively. The Vd and CL of futibatinib were reduced by 20.05% and 40.85%, respectively. T1/2 was extended from 3.88 h to 5.26 h. The results indicated that YCHD could affect the pharmacokinetics of futibatinib and increase the plasma exposure of futibatinib. If YCHD is administered along with futibatinib, this study gives a first impression how pharmacokinetics and toxicokinetics would change.

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通过HPLC-MS/MS分析银翘解毒片对福替尼药代动力学特征的影响

福替巴替尼是一种优良的成纤维细胞生长因子受体1-4（FGFR 1-4）抑制剂，对FGFR调控的肿瘤具有选择性抗肿瘤活性。本研究开发了一种新型高效液相色谱-串联质谱（HPLC-MS/MS）技术，用于定量分析小猎犬血浆中的氟替尼，并评估了银翘解毒片（YCHD）对氟替尼药代动力学的影响。血浆样品在碳酸钠碱性条件下经乙酸乙酯萃取处理后，采用C18色谱柱（4.6 mm×150, 5 μm）分离富替巴替尼和瑞培替尼（内标物，ISTD），流动相为甲醇和0.1%甲酸水溶液（60:40）。扫描方法采用多反应监测（MRM）模式，通过三重四极杆质谱仪进行正离子检测。富替替尼和IS的离子跃迁分别为m/z 419.20 → 296.15和m/z 510.36 → 417.00。福替替尼在 1-200 纳克/毫升范围内显示出良好的线性关系。日间和日内精密度均未超过 6.3%。准确度的%RE值介于-3.1%至0.9%之间。该方法的回收率、稳定性和基质效应均符合《中国药典》2020年版生物样品定量分析方法验证指南的要求。与YCHD联用，与单用相比，氟替替尼的Cmax增加了40.84%，AUC(0-t)和AUC(0-∞)分别增加了78.06%和82.71%。福替替尼的Vd和CL分别降低了20.05%和40.85%。结果表明，YCHD可影响福替替尼的药代动力学，增加福替替尼的血浆暴露量。如果YCHD与福替替尼同时给药，本研究将给出药代动力学和毒代动力学如何变化的初步印象。

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来源期刊

ACS Applied Bio Materials Chemistry-Chemistry (all)

CiteScore

9.40

自引率

2.10%

发文量

464

期刊介绍： ACS Applied Bio Materials is an interdisciplinary journal publishing original research covering all aspects of biomaterials and biointerfaces including and beyond the traditional biosensing, biomedical and therapeutic applications. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrates knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important bio applications. The journal is specifically interested in work that addresses the relationship between structure and function and assesses the stability and degradation of materials under relevant environmental and biological conditions.