Simultaneous quantification of mirabegron and vibegron in human plasma by HPLC-MS/MS and its application in the clinical determination in patients with tumors associated with overactive bladder

化学 蛋白质沉淀 色谱法 生物分析 甲酸 分析物 电喷雾电离 选择性反应监测 高效液相色谱法 质谱法 液相色谱-质谱法 串联质谱法
作者
Yutao Lou,Mengting Cheng,Qin Cao,Kening Li,Hui Qin,Meihua Bao,Yuan Zhang,Sisi Lin,Yiwen Zhang
出处
期刊:Journal of Pharmaceutical and Biomedical Analysis [Elsevier BV]
卷期号:240: 115937-115937
标识
DOI:10.1016/j.jpba.2023.115937
摘要

Mirabegron and vibegron, both newly identified beta-3 adrenergic agonists, have significantly improved the quality of life for patients suffering from overactive bladder. In order to comprehensively assess the plasma exposure levels of these agents, the development of a rapid and highly sensitive bioanalytical method becomes imperative. The primary objective of this study was to establish a robust high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the concurrent quantification of mirabegron and vibegron in human plasma. The analytes were extracted from a 100 μL plasma sample through protein precipitation, employing 300 μL of methanol. Subsequently, samples underwent separation and quantification using a Waters XBridge C18 column (2.1 × 100 mm, 3.5 µm), with a mobile phase consisting of 0.1% formic acid in water and 0.1% formic acid in acetonitrile. The mass analysis was conducted using positive electrospray ionization (ESI+) operated in a multiple reaction monitoring (MRM) mode. The proposed method was meticulously validated in accordance with the guidelines set forth by the U.S. Food and Drug Administration (FDA) for bioanalytical method validation. The regression equations demonstrated exceptional linearity for both mirabegron (r² ≥ 0.994) and vibegron (r² ≥ 0.996) across the concentration range of 0.5 – 200 ng/mL. Furthermore, the assay exhibited accuracy (inter-day relative error ≤ 6.90%) and precision (inter-day coefficient of variation ≤ 8.88%). The average recoveries of the analytes were found to range from 81.94% to 102.02%, with mean matrix effects falling within the range of 89.77% to 110.58%. As a result, this method was deemed highly suitable for the precise determination of the concentrations of both mirabegron and vibegron in the context of therapeutic drug monitoring and bioequivalence studies.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
量子星尘发布了新的文献求助10
1秒前
男子无才便是德完成签到,获得积分10
2秒前
2秒前
yuhangcao完成签到,获得积分10
2秒前
乐乐应助皮老师采纳,获得10
2秒前
SciGPT应助雪山飞龙采纳,获得10
3秒前
3秒前
隐形曼青应助anna采纳,获得10
4秒前
谦让成协完成签到,获得积分10
5秒前
SuperD发布了新的文献求助10
5秒前
sumugeng完成签到,获得积分10
6秒前
耍酷问兰发布了新的文献求助10
6秒前
6秒前
小宋爱科研完成签到 ,获得积分10
8秒前
YJ888发布了新的文献求助10
8秒前
赘婿应助孙亦沈采纳,获得10
9秒前
10秒前
12秒前
李爱国应助张于小丸子采纳,获得10
12秒前
laz完成签到,获得积分10
13秒前
14秒前
14秒前
ding应助老吴采纳,获得10
14秒前
15秒前
16秒前
MTRQ发布了新的文献求助10
16秒前
18秒前
Liufgui应助麦克阿宇采纳,获得10
18秒前
科研通AI2S应助Lily采纳,获得10
19秒前
皮老师发布了新的文献求助10
20秒前
20秒前
CNAxiaozhu7完成签到,获得积分10
21秒前
21秒前
Joey完成签到,获得积分10
22秒前
木乙发布了新的文献求助10
23秒前
Ch_7发布了新的文献求助10
23秒前
善学以致用应助leslie采纳,获得10
24秒前
25秒前
25秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989069
求助须知:如何正确求助?哪些是违规求助? 3531351
关于积分的说明 11253589
捐赠科研通 3269939
什么是DOI,文献DOI怎么找? 1804851
邀请新用户注册赠送积分活动 882074
科研通“疑难数据库(出版商)”最低求助积分说明 809073