{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T21:14:28Z","timestamp":1788556468809,"version":"build-2803163510"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T00:00:00Z","timestamp":1788134400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Industrial Strategic Technology Development Program","award":["RS-2023-00230655"],"award-info":[{"award-number":["RS-2023-00230655"]}]},{"name":"Industrial Strategic Technology Development Program","award":["RS-2024-00439266"],"award-info":[{"award-number":["RS-2024-00439266"]}]},{"name":"Industrial Strategic Technology Development Program","award":["RS-2024-00438174"],"award-info":[{"award-number":["RS-2024-00438174"]}]},{"DOI":"10.13039\/501100003052","name":"Ministry of Trade, Industry and Energy","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003052","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,31]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Erectile dysfunction (ED) is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory performance for a duration of &amp;gt;3\u00a0months. However, chewable tadalafil formulations for treating ED and corresponding dissolution analysis methods for their quantification are lacking. Therefore, this study aims to investigate Quality by Design considerations for developing a reversed-phase high-performance liquid chromatography method. The test method was designed to perform a quantitative dissolution analysis of tadalafil chewable tablets to enhance medication compliance. This method required an Agilent C8 column (4.6\u2009\u00d7\u20095.0\u00a0cm, 5\u00a0\u03bcm) as the stationary phase and a mobile phase comprising a 1:1 methanol\u2013water mixture. The column temperature and detection wavelength were maintained at 40\u00b0C and 225\u00a0nm, respectively. The development and validation of the dissolution method resulted in a relative standard deviation of 0.03% for system suitability, assessed in a test solution containing a solubilizer. The test method demonstrated specificity by clearly distinguishing the active pharmaceutical ingredient from excipients. Tadalafil accuracy was confirmed with an average recovery rate of 100.22%, and the precision showed a relative standard deviation of 0.35%. Excellent linearity (R2\u2009=\u20091.000) was observed over the concentration range of 1.5\u00a0\u03bcg\/mL to 9.0\u00a0\u03bcg\/mL. Additionally, the detection and quantification limits for tadalafil were 0.003\u00a0\u03bcg\/mL and 0.008\u00a0\u03bcg\/mL, respectively. The developed method facilitated rapid quantification of tadalafil in chewable tablets, completing each run within 5\u00a0min and reducing analysis time by ~60% compared to conventional methods. Additionally, reagent consumption and operational costs were reduced by ~45%, improving overall efficiency. These findings validate the suitability of the method for reliable industrial quality control of tadalafil chewable tablets and new formulations.<\/jats:p>","DOI":"10.1093\/chromsci\/bmag025","type":"journal-article","created":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T11:35:08Z","timestamp":1786448108000},"source":"Crossref","is-referenced-by-count":0,"title":["QbD consideration for developing and validating the dissolution test method for quantitative analysis of tadalafil chewable tablets"],"prefix":"10.1093","volume":"64","author":[{"given":"Seung-Hyun","family":"Park","sequence":"first","affiliation":[{"name":"Department of Biopharmaceutical Chemistry, Kookmin University , 77 Jeongneung-ro, Seongbuk-gu, Seoul 02707, Republic of","place":["Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7744-8573","authenticated-orcid":false,"given":"Joo-Eun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Biopharmaceutical Chemistry, Kookmin University , 77 Jeongneung-ro, Seongbuk-gu, Seoul 02707, Republic of","place":["Korea"]},{"name":"Biopharmaceutical Chemistry Major, School of Applied Chemistry, Kookmin University , 77 Jeongneung-ro, Seongbuk-gu, Seoul 02707, Republic of","place":["Korea"]},{"name":"Department of Pharmaceutical engineering, Kookmin University , 77 Jeongneung-ro, Seongbuk-gu, Seoul 02707, Republic of","place":["Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,9,4]]},"reference":[{"key":"2026090416402846300_ref1","first-page":"149","article-title":"Preference for and adherence to oral phosphodiesterase-5 inhibitors in the treatment of erectile dysfunction","volume":"2","author":"Giannitsas","year":"2008","journal-title":"Patient Preference and 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