{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T10:44:36Z","timestamp":1771670676452,"version":"3.50.1"},"reference-count":0,"publisher":"Brazilian Journal of Analytical Chemistry","issue":"49","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Braz. J. Anal. Chem."],"published-print":{"date-parts":[[2025,5,21]]},"abstract":"<jats:p>This study aimed to develop and validate a stability-indicating method by high performance liquid chromatography to quantify the Oclacitinib (OCLA), on the presence of its degradation products (DPs), by applying Analytical Quality by Design (AQbD) strategy. underwent exposure to acid, alkaline, neutral, photolytic, oxidative, and thermal stress conditions, with degradation products observed under acidic and photolytic conditions. After defining the Analytical Target Profile, the tailing factor, peak purity, and last peak retention time were established as Critical Quality Attributes. The risk assessment led to the designation of the mobile and stationary phases, the oven temperature, the injection volume and the flow rate as Critical Method Parameters. A screening step was then performed to select categorical variables, and the significant factors were subsequently incorporated into the Box-Behnken Design for method optimization. The optimized method was achieved using Zorbax XBD C18 column (150 x 4.6 mm, 3.5 \u03bcm), oven temperature 17 \u00b0C, and injection volume 25 \u00b5L. The mobile phase consisted of ammonium formate buffer 100 mM, pH 3.1 and methanol, and a flow rate of 1.1 mL min-1, eluted by a stepwise gradient. Furthermore, the method demonstrated excellent selectivity and linearity (R&gt; 0.999). The theoretical limit of detection was determined to be 5.52 \u00b5g mL-1, while the theoretical limit of quantification was found to be 16.74 \u00b5g mL-1. Furthermore, precision and accuracy were demonstrated with a relative standard deviation below 2.0% and accuracy ranging from 99.87% to 101.38%. Hence, the method was successfully developed, optimized, and validated by applying AQbD approach, becoming a useful methodology for routine quality control of OCLA and its degradation products.<\/jats:p>","DOI":"10.30744\/brjac.2179-3425.ar-6-2024","type":"journal-article","created":{"date-parts":[[2025,5,22]],"date-time":"2025-05-22T09:01:16Z","timestamp":1747904476000},"source":"Crossref","is-referenced-by-count":1,"title":["Development and Validation of a Stability-Indicating High-Performance Liquid Chromatography with Diode-Array Detection Method for Oclacitinib Using Analytical Quality by Design Approach"],"prefix":"10.30744","volume":"12","author":[{"name":"Universidade Federal do Paran\u00e1","sequence":"first","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8525-1553","authenticated-orcid":false,"given":"Dalton","family":"Souza","sequence":"first","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3899-2300","authenticated-orcid":false,"given":"Danilo","family":"Momade","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6642-3928","authenticated-orcid":false,"given":"Alexandre","family":"Cobre","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1168-241X","authenticated-orcid":false,"given":"Allan","family":"Junkert","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8046-1875","authenticated-orcid":false,"given":"Dile","family":"Stremel","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3434-1239","authenticated-orcid":false,"given":"Raul","family":"Lazo","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9951-587X","authenticated-orcid":false,"given":"Luana","family":"Ferreira","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7049-4363","authenticated-orcid":false,"given":"Roberto","family":"Pontarolo","sequence":"additional","affiliation":[]}],"member":"12190","published-online":{"date-parts":[[2025,5,21]]},"container-title":["Brazilian Journal of Analytical Chemistry"],"original-title":[],"link":[{"URL":"https:\/\/www.brjac.com.br\/artigos\/brjac-6-2024.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T15:32:43Z","timestamp":1756827163000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.brjac.com.br\/artigos\/brjac-6-2024.pdf"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,21]]},"references-count":0,"journal-issue":{"issue":"49","published-online":{"date-parts":[[2025,5,21]]},"published-print":{"date-parts":[[2025,5,21]]}},"URL":"https:\/\/doi.org\/10.30744\/brjac.2179-3425.ar-6-2024","relation":{},"ISSN":["2179-3425","2179-3433"],"issn-type":[{"value":"2179-3425","type":"print"},{"value":"2179-3433","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,21]]}}}