{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:14:20Z","timestamp":1790813660328,"version":"4.1.0"},"reference-count":44,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,9,4]],"date-time":"2024-09-04T00:00:00Z","timestamp":1725408000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,9,4]],"date-time":"2024-09-04T00:00:00Z","timestamp":1725408000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    This study validates a stability\u2010indicating LC method for detecting organic impurities in the chlorzoxazone dosage form. Using a Waters X\u2010Select R HSS T3 analytical column, mobile phase of it was made by mixing of water, methanol, and glacial acetic acid in the ratio of 700:300:10 (v\/v\/v). The drug product and drug substance were subjected to the stress conditions such as acid, base, oxidation, heat, and photolysis as per the recommendations of the International Conference on Harmonization (Q2) methodology. The study revealed the susceptibility of 4\u2010chloro\u20102\u2010aminophenol to alkaline environments, emphasizing peak homogeneity and stability. The method verification, per ICH guidelines and USP&lt;1225&gt;, established precision, specificity, linearity, accuracy, and robustness for quality control. The mean impurity recovery ranged from 95.5% to 105.2%, the correlation coefficient (\n                    <jats:italic>r<\/jats:italic>\n                    ) was greater than 1.000, and the RSD values (\n                    <jats:italic>n<\/jats:italic>\n                    \u00a0=\u20096) ranged from 0.6% to 5.1% across the LOQ\u2013150% ranges. Full\u2010factorial design tested final method conditions, evaluating multiple parameters concurrently. Graphical optimization within the design space defined strong method requirements, ensuring consistent and reliable outcomes. The study develops and validates chlorzoxazone stability\u2010indicating methods, employing advanced statistical approaches like design of experiments and factorial design, with resilient conditions established through graphical optimization of the design space.\n                  <\/jats:p>","DOI":"10.1002\/bmc.6001","type":"journal-article","created":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T02:50:24Z","timestamp":1725504624000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Development, evaluation of critical method variables and stability assessment using a Box\u2013Behnken design for the determination of organic impurities in a pharmaceutical dosage form of a centrally acting muscle relaxant drug chlorzoxazone"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7094-9161","authenticated-orcid":false,"given":"Santhosh Kumar","family":"Ettaboina","sequence":"first","affiliation":[{"name":"Department of Chemistry, School of Applied Sciences and Humanities (SASH) VIGNAN'S Foundation for Science, Technology &amp; Research (VFSTR)  Vadlamudi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satyasree","family":"Nannapaneni","sequence":"additional","affiliation":[{"name":"Department of Chemistry, School of Applied Sciences and Humanities (SASH) VIGNAN'S Foundation for Science, Technology &amp; Research (VFSTR)  Vadlamudi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nagalakshmi","family":"Jeedimalla","sequence":"additional","affiliation":[{"name":"Laurus Generics, Inc.  Berkeley Heights New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8251-5005","authenticated-orcid":false,"given":"Thirupathi","family":"Dongala","sequence":"additional","affiliation":[{"name":"Agilent Technologies  Wilmington Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siva Krishna","family":"Muchakayala","sequence":"additional","affiliation":[{"name":"Analytical Research and Development Catalent Pharma Solutions  Winchester Virginia USA"},{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naresh Kumar","family":"Katari","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Hyderabad Telangana India"},{"name":"School of Chemistry &amp; Physics, College of Agriculture, Engineering &amp; Science Westville Campus, University of KwaZulu\u2010Natal  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,4]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.4236\/ajac.2016.76047"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/chromsci\/bmv029"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0039-9140(02)00421-6"},{"key":"e_1_2_7_5_1","first-page":"34","article-title":"Simultaneous determination of paracetamol, chlorzoxazone and diclofenac sodium in tablet dosage form by HPLC","volume":"2","author":"Chakraborty M.","year":"2012","journal-title":"International Journal of Pharmaceutical Innovations"},{"key":"e_1_2_7_6_1","first-page":"171","article-title":"Simultaneous determination of chlorzoxazone, paracetamol and diclofenac sodium by different chromatographic techniques","volume":"33","author":"Chawla J. 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