{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T13:21:43Z","timestamp":1788355303560,"version":"build-2803163510"},"reference-count":30,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"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>A direct enantio- and chemo-selective high-performance liquid chromatographic method was developed for determining the enantiomeric impurity of the chiral active pharmaceutical ingredient silodosin. The simultaneous separation of enantiomers of silodosin and its main organic related substances listed in the Japanese Pharmacopoeia (JP) monograph for drug substance was achieved on Chiralpak AD-3 (250 mm \u00d7 4.6 mm, 3 \u03bcm) column under normal-phase isocratic conditions. The optimized conditions employed the mixture n-heptane-ethanol-diethylamine (70:30:0.1) (v\/v\/v) as a mobile phase and a temperature of 35 \u00b0C. The complete separation of the enantiomers of silodosin and its main impurities was obtained within 12 min. The chromatographic method has been validated according to the International Conference on Harmonization (ICH) guidelines and compared with the method reported in the JP monograph. The standard curve for silodosin exhibited linearity (R2 &gt; 0.999) within the concentration range of 1.13\u20132500 \u00b5g mL\u22121. The Chiralpak AD-3 has demonstrated a remarkable level of efficiency, enabling the attainment of limits of quantitation for silodosin of 1.13 \u00b5g mL\u22121 (equivalent to 0.057% of a sample solution of 2 mg mL\u22121) and ranging from 0.48 \u00b5g mL\u22121 to 1.94 \u00b5g mL\u22121 for other impurities.<\/jats:p>","DOI":"10.3390\/molecules30091966","type":"journal-article","created":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T05:17:12Z","timestamp":1745903832000},"page":"1966","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Enantio- and Chemo-Selective HPLC Analysis of Silodosin on an Amylose-Based Chiral Stationary Phase"],"prefix":"10.3390","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0808-7644","authenticated-orcid":false,"given":"Daniele","family":"Sadutto","sequence":"first","affiliation":[{"name":"Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanit\u00e0, Viale Regina Elena 299, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-8597-0297","authenticated-orcid":false,"given":"Francesca Romana","family":"Mammone","sequence":"additional","affiliation":[{"name":"Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanit\u00e0, Viale Regina Elena 299, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"D\u2019Ettorre","sequence":"additional","affiliation":[{"name":"Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanit\u00e0, Viale Regina Elena 299, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leo","family":"Zanitti","sequence":"additional","affiliation":[{"name":"Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanit\u00e0, Viale Regina Elena 299, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"De Orsi","sequence":"additional","affiliation":[{"name":"Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanit\u00e0, Viale Regina Elena 299, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Romina","family":"Alfonsi","sequence":"additional","affiliation":[{"name":"Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanit\u00e0, Viale Regina Elena 299, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Prestinaci","sequence":"additional","affiliation":[{"name":"Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanit\u00e0, Viale Regina Elena 299, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6346-1953","authenticated-orcid":false,"given":"Roberto","family":"Cirilli","sequence":"additional","affiliation":[{"name":"Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanit\u00e0, Viale Regina Elena 299, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,4,29]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"88","DOI":"10.2174\/1871526517666170329123845","article-title":"Role of chirality in drugs: An overview","volume":"18","author":"Alkadi","year":"2018","journal-title":"Infect. 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