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已发表论文
UPLC-MS/MS 同时测定人血浆中维奈克拉和泊沙康唑：在急性髓系白血病患者治疗药物监测中的应用
Authors Chen X , Wu H, Fu H, Wang P, Cao L, Li R, Zhan R , Xu RA
Received 30 April 2025
Accepted for publication 5 December 2025
Published 12 January 2026 Volume 2026:20 537699
DOI https://doi.org/10.2147/DDDT.S537699
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Tuo Deng
Xiaohai Chen,* Hualu Wu,* Haoxin Fu, Peiqi Wang, Lu Cao, Ruibin Li, Ruanjuan Zhan, Ren-Ai Xu
Department of Pharmacy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Ruanjuan Zhan, Email zhanruanjuan@163.com Ren-Ai Xu, Email ysxurenai@hotmail.com
Background: Due to the high risk of invasive fungal disease (IFD) in acute myeloid leukemia (AML) patients, the antifungal drug posaconazole is often co-administered with venetoclax. As posaconazole is a potent inhibitor of CYP3A4, the standard dosing regimen may lead to the elevated plasma concentrations of venetoclax due to potential drug-drug interactions (DDIs). Therefore, therapeutic drug monitoring (TDM) is necessary to optimize the dosage.
Methods: This study developed and validated a rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous quantification of venetoclax and posaconazole in human plasma. Plasma samples were pretreated using acetonitrile precipitation. The chromatographic separation was achieved using an Acquity BEH C18 column with gradient elution. The mobile phase consisted of 0.1% formic acid in water and acetonitrile, with a flow rate of 0.4 mL/min.
Results: The method demonstrated good sensitivity and linearity within the concentration ranges of 10– 15,000 ng/mL for venetoclax and 10– 10,000 ng/mL for posaconazole, respectively. Additionally, the method showed acceptable selectivity, intra-day precision, inter-day precision, accuracy, matrix effects (95.2% to 102.0% for venetoclax and 98.4% to 102.5% for posaconazole), extraction recovery (93.2% to 95.4% for venetoclax and 87.8% to 95.8% for posaconazole), and stability under various conditions. The trough concentrations of venetoclax were 9326.88 ± 12,169.05 ng/mL in patients treated with venetoclax alone, and 31,623.55 ± 28,453.67 ng/mL in patients treated with venetoclax in combination with posaconazole.
Conclusion: A rapid and simple method was established and successfully applied to the simultaneous determination of the concentrations of venetoclax and posaconazole in AML patients, providing a basis for TDM and clinical pharmacokinetic analysis of these drugs in AML patients.
Keywords: invasive fungal disease, acute myeloid leukemia, therapeutic drug monitoring, UPLC-MS/MS
Department of Pharmacy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Ruanjuan Zhan, Email zhanruanjuan@163.com Ren-Ai Xu, Email ysxurenai@hotmail.com
Background: Due to the high risk of invasive fungal disease (IFD) in acute myeloid leukemia (AML) patients, the antifungal drug posaconazole is often co-administered with venetoclax. As posaconazole is a potent inhibitor of CYP3A4, the standard dosing regimen may lead to the elevated plasma concentrations of venetoclax due to potential drug-drug interactions (DDIs). Therefore, therapeutic drug monitoring (TDM) is necessary to optimize the dosage.
Methods: This study developed and validated a rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous quantification of venetoclax and posaconazole in human plasma. Plasma samples were pretreated using acetonitrile precipitation. The chromatographic separation was achieved using an Acquity BEH C18 column with gradient elution. The mobile phase consisted of 0.1% formic acid in water and acetonitrile, with a flow rate of 0.4 mL/min.
Results: The method demonstrated good sensitivity and linearity within the concentration ranges of 10– 15,000 ng/mL for venetoclax and 10– 10,000 ng/mL for posaconazole, respectively. Additionally, the method showed acceptable selectivity, intra-day precision, inter-day precision, accuracy, matrix effects (95.2% to 102.0% for venetoclax and 98.4% to 102.5% for posaconazole), extraction recovery (93.2% to 95.4% for venetoclax and 87.8% to 95.8% for posaconazole), and stability under various conditions. The trough concentrations of venetoclax were 9326.88 ± 12,169.05 ng/mL in patients treated with venetoclax alone, and 31,623.55 ± 28,453.67 ng/mL in patients treated with venetoclax in combination with posaconazole.
Conclusion: A rapid and simple method was established and successfully applied to the simultaneous determination of the concentrations of venetoclax and posaconazole in AML patients, providing a basis for TDM and clinical pharmacokinetic analysis of these drugs in AML patients.
Keywords: invasive fungal disease, acute myeloid leukemia, therapeutic drug monitoring, UPLC-MS/MS