{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T00:59:21Z","timestamp":1785459561865,"version":"3.56.0"},"reference-count":10,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2022,4,22]],"date-time":"2022-04-22T00:00:00Z","timestamp":1650585600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>Dapoxetine is used for the treatment of premature ejaculation. The present study developed an HPLC\u2013MS\/MS method to determine the levels of dapoxetine in human plasma processed using simple protein precipitation. Dapoxetine-d7 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\u2013157.2 and m\/z 313.2\u2013164.2 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.<\/jats:p>","DOI":"10.3390\/molecules27092707","type":"journal-article","created":{"date-parts":[[2022,4,23]],"date-time":"2022-04-23T21:39:45Z","timestamp":1650749985000},"page":"2707","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC\u2013MS\/MS and Its Application in a Bioequivalence Study"],"prefix":"10.3390","volume":"27","author":[{"given":"Xin","family":"Zhang","sequence":"first","affiliation":[{"name":"Guangzhou Higher Education Mega Center, School of Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, No. 232, Waihuandong Road, Guangzhou 510006, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhanwang","family":"Gao","sequence":"additional","affiliation":[{"name":"Guangzhou Higher Education Mega Center, School of Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, No. 232, Waihuandong Road, Guangzhou 510006, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Qin","sequence":"additional","affiliation":[{"name":"Baiyunshan Pharmaceutical General Factory, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd., Guangzhou 510515, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kehan","family":"Chen","sequence":"additional","affiliation":[{"name":"Guangzhou Higher Education Mega Center, School of Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, No. 232, Waihuandong Road, Guangzhou 510006, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiansong","family":"Wang","sequence":"additional","affiliation":[{"name":"Baiyunshan Pharmaceutical General Factory, Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd., Guangzhou 510515, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2756-5346","authenticated-orcid":false,"given":"Lingli","family":"Wang","sequence":"additional","affiliation":[{"name":"Guangzhou Higher Education Mega Center, School of Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, No. 232, Waihuandong Road, Guangzhou 510006, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,4,22]]},"reference":[{"key":"ref_1","first-page":"5","article-title":"Premature ejaculation\u2014Current concepts in the management: A narrative review","volume":"19","author":"Raveendran","year":"2021","journal-title":"Int. J. Reprod. Biomed."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1077","DOI":"10.1080\/14656566.2018.1494725","article-title":"Drug treatment options for premature ejaculation","volume":"19","author":"Waldinger","year":"2018","journal-title":"Expert Opin. Pharmacother."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"e13135","DOI":"10.1111\/and.13135","article-title":"Effect of premature ejaculation desensitisation therapy combined with dapoxetine hydrochloride on the treatment of primary premature ejaculation","volume":"51","author":"Fu","year":"2019","journal-title":"Andrologia"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"366","DOI":"10.5144\/0256-4947.2018.366","article-title":"Dapoxetine for the treatment of premature ejaculation: A meta-analysis of randomized controlled trials with trial sequential analysis","volume":"38","author":"Li","year":"2018","journal-title":"Ann. Saudi Med."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"7269","DOI":"10.1038\/srep07269","article-title":"The role of dapoxetine hydrochloride on-demand for the treatment of men with premature ejaculation","volume":"4","author":"Ren","year":"2014","journal-title":"Sci. Rep."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1016\/j.jare.2020.04.019","article-title":"Enhanced pharmacokinetic performance of dapoxetine hydrochloride via the formulation of instantly-dissolving buccal films with acidic pH modifier and hydrophilic cyclodextrin: Factorial analysis, in vitro and in vivo assessment","volume":"24","author":"Aldawsari","year":"2020","journal-title":"J. Adv. Res."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"384","DOI":"10.1002\/cpdd.866","article-title":"Bioequivalence Analysis of 2 Dapoxetine Hydrochloride Formulations in Healthy Chinese Male Volunteers Under Fed and Fasting Conditions: A Randomized, Open-Label, 2-Sequence, 2-Period, 2-Way Crossover Study","volume":"10","author":"Yan","year":"2021","journal-title":"Clin. Pharmacol. Drug Dev."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1216","DOI":"10.1002\/cpdd.919","article-title":"Pharmacokinetics and Safety of Dapoxetine Hydrochloride in Healthy Chinese Men: Impact of Dose and High-Fat Meal","volume":"10","author":"Liu","year":"2021","journal-title":"Clin. Pharmacol. Drug Dev."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1306","DOI":"10.1002\/bio.3566","article-title":"Validated spectrophotometric and spectrofluorimetric methods for determination of dapoxetine hydrochloride and dosulepin hydrochloride in their dosage forms using mercurochrome","volume":"33","author":"Elama","year":"2018","journal-title":"Luminescence"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1093\/chromsci\/bmz115","article-title":"A Validated Green HPTLC Method for Quantitative Determination of Dapoxetine Hydrochloride and Tadalafil in Bulk and Pharmaceutical Formulations","volume":"58","author":"Naguib","year":"2020","journal-title":"J. Chromatogr. Sci."}],"container-title":["Molecules"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1420-3049\/27\/9\/2707\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T22:58:58Z","timestamp":1760137138000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1420-3049\/27\/9\/2707"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,22]]},"references-count":10,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2022,5]]}},"alternative-id":["molecules27092707"],"URL":"https:\/\/doi.org\/10.3390\/molecules27092707","relation":{},"ISSN":["1420-3049"],"issn-type":[{"value":"1420-3049","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4,22]]}}}