{"title":"Identification of a novel vardenafil analogue, 19-O-propyl hydroxy vardenafil, as a dietary supplement adulterant.","authors":"Hui-Chun Lee, You-Lun Wu, Yu-Ting Lin, Li-Yao Tsai, Ya-Min Kao, Mei-Chih Lin, Su-Hsiang Tseng","doi":"10.1016/j.jpba.2024.116563","DOIUrl":null,"url":null,"abstract":"<p><p>A novel vardenafil analogue was discovered during adulterant screening of a dietary supplement. After extraction and purification, this analogue was identified using liquid chromatography-high resolution mass spectrometry (LC-HRMS) and nuclear magnetic resonance (NMR) analyses. The molecular formula determined using LC-HRMS was C<sub>24</sub>H<sub>34</sub>N<sub>6</sub>O<sub>5</sub>S. Fragmentation data suggested that this unknown compound may have two modifications to vardenafil. NMR analysis confirmed the presence of a hydroxyl group on the piperazine moiety and a propyl group attached to the phenoxy group. Consequently, this compound was named 19-O-propyl hydroxy vardenafil.</p>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of pharmaceutical and biomedical analysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jpba.2024.116563","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
引用次数: 0
Abstract
A novel vardenafil analogue was discovered during adulterant screening of a dietary supplement. After extraction and purification, this analogue was identified using liquid chromatography-high resolution mass spectrometry (LC-HRMS) and nuclear magnetic resonance (NMR) analyses. The molecular formula determined using LC-HRMS was C24H34N6O5S. Fragmentation data suggested that this unknown compound may have two modifications to vardenafil. NMR analysis confirmed the presence of a hydroxyl group on the piperazine moiety and a propyl group attached to the phenoxy group. Consequently, this compound was named 19-O-propyl hydroxy vardenafil.
期刊介绍：
This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome.
Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.
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