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Cited by 12Analytical Methods in PharmaceuticalsBiosimilars and Bioanalytical MethodsForensic Toxicology and Drug Analysis

Development and validation of a UPLC–MS/MS method for quantitation of droxidopa in human plasma: Application to a pharmacokinetic study

Wang, Haidong, Yang, Guangsheng, Zhou, Jinyu, Pei, Jiang, Zhang, Qiangfeng, Song, Xingfa, Sun, Zengxian·2016·Journal of Chromatography B
DOI 10.1016/j.jchromb.2016.04.056
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Abstract

In this study, a simple and sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for quantitation of droxidopa in human plasma for the first time. A simple plasma protein precipitation method using methanol containing 3% formic acid was selected, and the separation was achieved by an Acquity UPLC™ BEH Amide column (2.1mm×50mm, 1.7μm) with a gradient elution using acetonitrile, ammonium formate buffer and formic acid as mobile phase. The detection of droxidopa and benserazide (internal standard, IS) was performed using positive-ion electrospray tandem mass spectrometry via multiple reaction monitoring (MRM). The precursor-to-product ion transitions m/z 214.2→m/z 152.0 for droxidopa, and m/z 258.1→m/z 139.1 for IS were used for quantification. A lower limit of quantification of 5.00ng/mL was achieved and the linear curve range was 5.00-4000ng/mL using a weighted (1/x(2)) linear regression model. Intra-assay and inter-assay precision was less than 10.2%, and the accuracy ranged from 0.1% to 2.1%. Stability, recovery and matrix effects were within the acceptance criteria recommended by the regulatory bioanalytical guidelines. The method was successfully applied to a pharmacokinetic study of droxidopa in healthy Chinese volunteers.

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  • Droxidopa is an orally active, synthetic prodrug of norepinephrine that reaches peak plasma concentration in 2 h.

    “Droxidopa is an orally active, synthetic prodrug of norepinephrine that reaches peak plasma concentration in 2 h (57).”

    From Postural orthostatic tachycardia syndrome: mechanisms and new therapies (2020) · cites this paper as [57]

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Authors
Wang, H., Yang, G., Zhou, J., Pei, J., Zhang, Q., Song, X., & Sun, Z.
Affiliations
  • The First People’s Hospital of Lianyungang (CN)
  • Jining First People's Hospital (CN)
Corresponding author
Sun, Zengxian
ORCID
Venue
Journal of Chromatography B
Publisher
Elsevier BV
Published
2016-08
Volume
1027
Pages
234-238
ISSN
1570-0232 (ISSN-L)
DOI
10.1016/j.jchromb.2016.04.056
OpenAlex
W2358651311
Cited by
12
References
19
Citations by year
2026: 1 · 2025: 1 · 2023: 3 · 2021: 1 · 2019: 3 · 2018: 1 · 2017: 2
FWCI
1.58
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Chromatography B (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
  • Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
Keywords
droxidopa, UPLC-MS/MS, plasma quantitation, bioanalytical method validation, pharmacokinetics, plasma protein precipitation, multiple reaction monitoring, healthy volunteers
MeSH terms
Adult, Animals, Antiparkinson Agents, Chromatography, High Pressure Liquid, Humans, Male, Droxidopa, Reproducibility of Results, Tandem Mass Spectrometry, Limit of Detection

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