干旱区生态环境知识资源中心(Arid): Development of a Sensitive and High-Throughput Assay for Simultaneous Quantification of 5 Tyrosine Kinase Inhibitors and 2 Active Metabolites in Human Plasma Using Ultra-high Performance Liquid Chromatography Coupled to Tandem Mass Spectrometry

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DOI	10.1097/FTD.0000000000000922
	Development of a Sensitive and High-Throughput Assay for Simultaneous Quantification of 5 Tyrosine Kinase Inhibitors and 2 Active Metabolites in Human Plasma Using Ultra-high Performance Liquid Chromatography Coupled to Tandem Mass Spectrometry
	Sumimoto, Takahiro; Nakahara, Ryosuke; Suzuki, Yosuke; Tanaka, Ryota; Yoshida, Natsumi; Ogata, Masao; Itoh, Hiroki
通讯作者	Sumimoto, T
来源期刊	THERAPEUTIC DRUG MONITORING
ISSN	0163-4356
EISSN	1536-3694
出版年	2022
卷号	44 期号:3 页码:419-429
英文摘要	Background: Breakpoint cluster region-Abelson (BCR-ABL) tyrosine kinase inhibitors (TKIs) demonstrate improved therapeutic efficacy in chronic myeloid leukemia (CML). However, drug-drug interactions, nonadherence, and host-related factors may influence plasma concentrations. Therefore, therapeutic drug monitoring may be necessary for patients presenting inadequate treatment responses or adverse events. Herein, the authors aimed to develop a more sensitive and high-throughput method than those previously reported to simultaneously quantify 5 TKIs (imatinib, nilotinib, dasatinib, bosutinib, and ponatinib) and 2 active metabolites (N-desmethyl imatinib and N-desmethyl ponatinib) using ultra-performance liquid chromatography coupled with tandem mass spectrometry. Methods: Plasma samples were prepared according to a solid-phase extraction protocol using an Oasis MCX mu Elution plate. The assay fulfilled the requirements of the US Food and Drug Administration for assay validation, with a lower limit of quantification of 0.2 ng/mL for dasatinib, 0.3 ng/mL for N-desmethyl ponatinib, 0.5 ng/mL for N-desmethyl imatinib, bosutinib, and ponatinib, and 2.5 ng/mL for imatinib and nilotinib. Results: Within-batch and batch-to-batch precision at the lower limit of quantification and quality control levels were within 14.3% and 10.9%, respectively. Within-batch and batch-to-batch accuracies ranged from 15.5% to 13.0% and 5.70% to 7.03%, respectively. A positive electrospray ionization mode was used with a run time of 6.0 minutes. The assay applicability was verified by the successful measurement of 78 clinical samples from patients undergoing CML therapy. Conclusions: The method allows assessment of trough concentrations of TKIs and active metabolites in patients with CML, and hence can be used to assess blood samples in routine clinical settings.
英文关键词	ultra-high performance liquid chromatography tandem mass spectrometry solid-phase extraction tyrosine kinase inhibitor leukemia
类型	Article
语种	英语
收录类别	SCI-E
WOS记录号	WOS:000793999100011
WOS关键词	CHRONIC MYELOID-LEUKEMIA ; BCR-ABL ; IMATINIB ; PONATINIB ; PHARMACOKINETICS ; RECOMMENDATIONS ; FLUORESCENCE ; DASATINIB
WOS类目	Medical Laboratory Technology ; Pharmacology & Pharmacy ; Toxicology
WOS研究方向	Medical Laboratory Technology ; Pharmacology & Pharmacy ; Toxicology
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/394726
推荐引用方式 GB/T 7714	Sumimoto, Takahiro,Nakahara, Ryosuke,Suzuki, Yosuke,et al. Development of a Sensitive and High-Throughput Assay for Simultaneous Quantification of 5 Tyrosine Kinase Inhibitors and 2 Active Metabolites in Human Plasma Using Ultra-high Performance Liquid Chromatography Coupled to Tandem Mass Spectrometry[J],2022,44(3):419-429.
APA	Sumimoto, Takahiro.,Nakahara, Ryosuke.,Suzuki, Yosuke.,Tanaka, Ryota.,Yoshida, Natsumi.,...&Itoh, Hiroki.(2022).Development of a Sensitive and High-Throughput Assay for Simultaneous Quantification of 5 Tyrosine Kinase Inhibitors and 2 Active Metabolites in Human Plasma Using Ultra-high Performance Liquid Chromatography Coupled to Tandem Mass Spectrometry.THERAPEUTIC DRUG MONITORING,44(3),419-429.
MLA	Sumimoto, Takahiro,et al."Development of a Sensitive and High-Throughput Assay for Simultaneous Quantification of 5 Tyrosine Kinase Inhibitors and 2 Active Metabolites in Human Plasma Using Ultra-high Performance Liquid Chromatography Coupled to Tandem Mass Spectrometry".THERAPEUTIC DRUG MONITORING 44.3(2022):419-429.