Sensitive and rapid quantitation of dexamethasone in human plasma using liquid chromatography coupled with triple quadrupole mass spectrometer

Author:

Dubey Naveen Kumar1ORCID,Jain Peeyush1

Affiliation:

1. Bioanalytical Department, Jubilant Generics Limited, Noida, India

Abstract

The aim of this paper was to develop, validate, and utilize a sensitive liquid chromatography-tandem mass spectrometry bioanalytical method for bioequivalence/clinical trial studies conducted in human plasma. To accomplish the target, a stable labeled internal standard, that is, dexamethasone D4was used as an internal standard to track and compensate the parent compound during processing, and extraction from plasma. The method involves a rapid liquid–liquid phase extraction from plasma, followed by reverse phase chromatography, and mass spectrometry detection, with a total run time of 3.5 min. The method was developed and validated from 2 to 600 ng/ml for dexamethasone. The mean recovery for dexamethasone was found to be 81.0%. The validated method enabled the analysis of dexamethasone in samples from clinical pharmacokinetic studies. The peak concentration of dexamethasone ranged between 253 to 281 ng/ml and 319 to 343 ng/ml, respectively, in fasted and fed conditions. The terminal half-life values for dexamethasone ranged between 3.5 to 8.2 h and 3.0 to 7.5 h, respectively.

Publisher

SAGE Publications

Subject

Spectroscopy,Atomic and Molecular Physics, and Optics,General Medicine

Reference23 articles.

1. Dexamethasone and its properties. https://en.wikipedia.org/wiki/Dexamethasone (accessed 11 June 2022).

2. EMA-Dexamethasone Alapis Assessment report. 2011. https://www.ema.europa.eu/en/documents/referral/dexamethasone-alapis-article-29-referral-assessment-report_en.pdf (accessed on 18 May 2022).

3. New Drug Application-NDA-11-664/S-062. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11664slr062_decadron_lbl.pdf (accessed on 18 May 2022).

4. Center for drug evaluation and research, application number: 211379Orig1s000, clinical pharmacology and biopharmaceutics review(S). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211379Orig1s000ClinPharmR.pdf (accessed on 19 May 2022)

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3