利用 LC-QqQ-MS/MS 开发和验证小鼠血浆中多西他赛和香芹酚的生物分析方法。

IF 1.1 4区 化学 Q4 PHYSICS, ATOMIC, MOLECULAR & CHEMICAL
European Journal of Mass Spectrometry Pub Date : 2024-10-01 Epub Date: 2024-10-21 DOI:10.1177/14690667241289001
Shiva Kumar Gogikar, Sibu Sen, Sandeep Daravath, Mayur Aalhate, Srushti Mahajan, Mohd Aman Mohd Ateeq, Pankaj Kumar Singh, Amol G Dikundwar
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引用次数: 0

摘要

本研究介绍了一种基于液相色谱串联质谱的生物分析方法,用于可靠地同时定量检测小鼠血浆中的多西他赛(DXL)和香芹酚(CVL)。以紫杉醇为内标,建立并优化了小鼠血浆中多西他赛和香芹酚的快速灵敏生物分析方法。根据 ICH M10 指南对该生物分析方法进行了验证,小鼠血浆中这两种分析物的低浓度、中浓度和高质量对照浓度分别为 28.86 ng/mL、961.54 ng/mL 和 1346.15 ng/mL,范围为 9.62-1923.08 ng/mL。对准确度、精密度、迁移试验、基质效应和再注射重现性等验证参数进行了检测,结果均在限值范围内。进行了稳定性研究(台式、自动进样器、冻融和长期),结果均在限值范围内。所开发的生物分析方法适用于小鼠血浆中 DXL 和 CVL 的同时定量分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Bioanalytical method development and validation of docetaxel and carvacrol in mice plasma using LC-QqQ-MS/MS.

Present work describes the development of a liquid chromatography tandem mass spectrometry-based bioanalytical method for the reliable simultaneous quantification of docetaxel (DXL) and carvacrol (CVL) in the mice plasma. A rapid and sensitive bioanalytical method was developed and optimized in mice plasma using Paclitaxel as an internal standard. Validation of the bioanalytical method was performed according to the ICH M10 guideline covering the range of 9.62-1923.08 ng/mL in the mice plasma milleu at the low, mid, and high-quality control concentrations of 28.86 ng/mL, 961.54 ng/mL, and 1346.15 ng/mL, respectively for both the analytes. Validation parameters such as accuracy, precision, carryover-test, matrix effect, and reinjection reproducibility were carried out and were found in limits. Stability studies (Benchtop, autosampler, freeze-thaw, and long-term) were performed and found to be within limits. The developed bioanalytical method was found to be suitable for the simultaneous quantification of DXL and CVL in the mice plasma.

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来源期刊
CiteScore
2.40
自引率
7.70%
发文量
16
审稿时长
>12 weeks
期刊介绍: JMS - European Journal of Mass Spectrometry, is a peer-reviewed journal, devoted to the publication of innovative research in mass spectrometry. Articles in the journal come from proteomics, metabolomics, petroleomics and other areas developing under the umbrella of the “omic revolution”.
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