{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T11:25:24Z","timestamp":1788521124661,"version":"build-2803163510"},"reference-count":78,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,6,8]],"date-time":"2025-06-08T00:00:00Z","timestamp":1749340800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003359","name":"Generalitat Valenciana","doi-asserted-by":"publisher","award":["CIAICO\/2022\/198"],"award-info":[{"award-number":["CIAICO\/2022\/198"]}],"id":[{"id":"10.13039\/501100003359","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:label\/><jats:p>Alpha\u2010lipoic acid (ALA) is a natural antioxidant with therapeutic potential, but no method currently quantifies ALA in ocular structures. This study utilizes beta\u2010cyclodextrins (\u03b2\u2010CD) and (2\u2010hydroxypropyl)\u2010\u03b2\u2010cyclodextrins (HP\u2010\u03b2\u2010CD) to enhance ALA solubility and stability in 1:1\u2009M ratio. This study aims to optimize and validate a method for quantifying ALA in CD complexes using high\u2010performance liquid chromatography with ultraviolet detection (HPLC\u2010UV) and to perform a diffusion study to evaluate ALA's permeability in ocular tissue. The HPLC method employed a C18 column (150\u2009\u00d7\u20094.6\u2009mm, 5\u2009\u03bcm particle size) with an isocratic mobile phase of acetonitrile and water (50:50, v\/v) at pH\u20094.0, a flow rate of 1\u2009mL\/min, detected ALA after 4.8\u2009min at a wavelength of 334\u2009nm. Validation of the method was conducted according to the ICH guideline M10 on bioanalytical method validation. The stability study revealed that better stability was obtained for ALA in \u03b2\u2010CD inclusion in comparison with HP\u2010\u03b2\u2010CD. The <jats:italic>ex vivo<\/jats:italic> study using Franz diffusion cells was performed to confirm that ALA was able to permeate through the cornea and sclera via ocular administration. This accurate and precise HPLC\u2010UV method paves the way for future research into ALA's potential to alleviate ocular conditions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Summary<\/jats:title><jats:p>\n<jats:list list-type=\"bullet\">\n\n<jats:list-item><jats:p>This study optimized and validated a precise and accurate HPLC\u2010UV method for quantifying ALA in CD complexes, following ICH guideline M10 on bioanalytical method validation.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>Stability studies revealed that \u03b2\u2010CD complexes provided better thermal and solubility stability for ALA compared to HP\u2010\u03b2\u2010CD complexes.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>The <jats:italic>ex vivo<\/jats:italic> diffusion study confirmed that ALA successfully permeated the cornea and sclera via ocular administration.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>The validated method lays the groundwork for future research on ALA's potential to alleviate complications associated with ocular diseases.<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:p><\/jats:sec>","DOI":"10.1002\/bmc.70133","type":"journal-article","created":{"date-parts":[[2025,6,9]],"date-time":"2025-06-09T02:21:37Z","timestamp":1749435697000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Optimization and Validation of a High\u2010Performance Liquid Chromatography (HPLC\u2010UV) Method for Quantification of \u03b1\u2010Lipoic Acid in Cyclodextrins Complex for Ocular Delivery"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2933-1108","authenticated-orcid":false,"given":"Phuong\u00a0Linh","family":"Ta","sequence":"first","affiliation":[{"name":"Department of Biomedical Sciences, School of Health Sciences Universidad Cardenal Herrera\u2010CEU, CEU Universities  Alfara del Patriarca Valencia 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