{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T20:38:25Z","timestamp":1793565505882,"version":"4.5.0"},"reference-count":32,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,6,23]],"date-time":"2025-06-23T00:00:00Z","timestamp":1750636800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Strong understandings of science and risk evaluation methodologies are needed to design an analytical method for pharmaceutical quality assessment. This article provides an HPLC method for separating and quantifying baclofen and related impurities. The technique used a Waters Symmetry C<jats:sub>18<\/jats:sub> column, 250\u2009\u00d7\u20094.6\u2009mm, 5\u2009\u03bcm in gradient mode. Mobile Phase A was prepared by dissolving 0.0128\u2009M of 1\u2010octane sulfonic acid sodium salt in water, followed by the addition of 1\u2009mL of orthophosphoric acid and 2\u2009mL of tetrabutylammonium hydroxide to make up to a solution of 1\u2009L. Mobile Phase B was a homogenous mixture of methanol and water in a 900:100 (v\/v) ratio. A 0.7\u2010mL\/min flow rate was maintained for 60\u2009min. The sample cooler and column temperatures were kept at 25\u00b0C and 32\u00b0C with a 10\u2010\u03bcL injection volume. The detecting wavelength was 225\u2009nm. The drug product and material were subjected to acidity, base, oxidation, heat, and photolysis according to International Conference on Harmonization (Q2) criteria. A linear response (<jats:italic>R<\/jats:italic><jats:sup>2<\/jats:sup>\u2009&gt;\u20090.999), accuracy (recoveries 97.1%\u2013102.5%), precision (RS\u2009\u2264\u20095.0%), sensitivity, and specificity were demonstrated by the proposed method. This method ensures reliable analytical performance by cleanly separating compounds. Final method conditions were assessed using a full\u2010factorial design. Graphical optimization from the design space identified robust technique conditions.<\/jats:p>","DOI":"10.1002\/bmc.70129","type":"journal-article","created":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T00:30:47Z","timestamp":1750725047000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Development and Validation of an RP\u2010HPLC Method for Organic Impurity Profiling in Baclofen Utilizing Robustness Through a Quality\u2010by\u2010Design (QbD) Approach: A Comprehensive Forced Degradation Assessment"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7094-9161","authenticated-orcid":false,"given":"Santhosh\u00a0Kumar","family":"Ettaboina","sequence":"first","affiliation":[{"name":"Department of Chemistry Vignan's Foundation for Science Technology &amp; Research  Guntur Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satyasree","family":"Nannapaneni","sequence":"additional","affiliation":[{"name":"Department of Chemistry Vignan's Foundation for Science Technology &amp; Research  Guntur Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5737-8528","authenticated-orcid":false,"given":"Naresh\u00a0Kumar","family":"Katari","sequence":"additional","affiliation":[{"name":"School of Chemistry &amp; Physics, College of Agriculture, Engineering &amp; Science University of KwaZulu\u2010Natal, Westville Campus  Durban South Africa"},{"name":"Research &amp; Development CHEMTEX Environmental Laboratory Inc.  Port Arthur Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijay\u00a0Kumar","family":"Chollety","sequence":"additional","affiliation":[{"name":"Analytical Research and Development Ascent Pharmaceuticals Inc.  New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,23]]},"reference":[{"issue":"2","key":"e_1_2_9_2_1","first-page":"544","article-title":"Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Determination of Baclofen","volume":"7","author":"Adhao V. 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