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Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC–MS/MS and Its Application in a Bioequivalence Study
Dapoxetine is used for the treatment of premature ejaculation. The present study developed an HPLC–MS/MS method to determine the levels of dapoxetine in human plasma processed using simple protein precipitation. Dapoxetine-d(7) was selected as the internal standard. The established method was perfor...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9101379/ https://www.ncbi.nlm.nih.gov/pubmed/35566058 http://dx.doi.org/10.3390/molecules27092707 |
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author | Zhang, Xin Gao, Zhanwang Qin, Fei Chen, Kehan Wang, Jiansong Wang, Lingli |
author_facet | Zhang, Xin Gao, Zhanwang Qin, Fei Chen, Kehan Wang, Jiansong Wang, Lingli |
author_sort | Zhang, Xin |
collection | PubMed |
description | Dapoxetine is used for the treatment of premature ejaculation. The present study developed an HPLC–MS/MS method to determine the levels of dapoxetine in human plasma processed using simple protein precipitation. Dapoxetine-d(7) was selected as the internal standard. The established method was performed using a mass spectrometer equipped with an electrospray ionization source in multiple positive ion reactions to monitor the mode using the precursor-to-product ion transitions of m/z 306.2–157.2 and m/z 313.2–164.2 for dapoxetine-d7 and dapoxetine, respectively. The method was evaluated based on its selectivity, linearity, limit of quantification, precision, accuracy, matrix effects, dilution integrity, stability, and extraction recovery. As a result of the model used in the present study, the validated linear ranges of dapoxetine were determined to be 2.00~1000 ng/mL in plasma, and the selectivity, precision, accuracy, dilution integrity, stability, and extraction recovery met the accepted standard. No matrix interference was observed. The method was successfully validated and applied to pharmacokinetic studies in healthy Chinese volunteers during the fasting and postprandial periods, respectively. |
format | Online Article Text |
id | pubmed-9101379 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-91013792022-05-14 Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC–MS/MS and Its Application in a Bioequivalence Study Zhang, Xin Gao, Zhanwang Qin, Fei Chen, Kehan Wang, Jiansong Wang, Lingli Molecules Article Dapoxetine is used for the treatment of premature ejaculation. The present study developed an HPLC–MS/MS method to determine the levels of dapoxetine in human plasma processed using simple protein precipitation. Dapoxetine-d(7) was selected as the internal standard. The established method was performed using a mass spectrometer equipped with an electrospray ionization source in multiple positive ion reactions to monitor the mode using the precursor-to-product ion transitions of m/z 306.2–157.2 and m/z 313.2–164.2 for dapoxetine-d7 and dapoxetine, respectively. The method was evaluated based on its selectivity, linearity, limit of quantification, precision, accuracy, matrix effects, dilution integrity, stability, and extraction recovery. As a result of the model used in the present study, the validated linear ranges of dapoxetine were determined to be 2.00~1000 ng/mL in plasma, and the selectivity, precision, accuracy, dilution integrity, stability, and extraction recovery met the accepted standard. No matrix interference was observed. The method was successfully validated and applied to pharmacokinetic studies in healthy Chinese volunteers during the fasting and postprandial periods, respectively. MDPI 2022-04-22 /pmc/articles/PMC9101379/ /pubmed/35566058 http://dx.doi.org/10.3390/molecules27092707 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Zhang, Xin Gao, Zhanwang Qin, Fei Chen, Kehan Wang, Jiansong Wang, Lingli Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC–MS/MS and Its Application in a Bioequivalence Study |
title | Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC–MS/MS and Its Application in a Bioequivalence Study |
title_full | Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC–MS/MS and Its Application in a Bioequivalence Study |
title_fullStr | Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC–MS/MS and Its Application in a Bioequivalence Study |
title_full_unstemmed | Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC–MS/MS and Its Application in a Bioequivalence Study |
title_short | Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC–MS/MS and Its Application in a Bioequivalence Study |
title_sort | determination of dapoxetine hydrochloride in human plasma by hplc–ms/ms and its application in a bioequivalence study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9101379/ https://www.ncbi.nlm.nih.gov/pubmed/35566058 http://dx.doi.org/10.3390/molecules27092707 |
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