{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T14:17:26Z","timestamp":1776262646599,"version":"3.50.1"},"reference-count":13,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T00:00:00Z","timestamp":1773619200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T00:00:00Z","timestamp":1773619200000},"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":[[2026,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>This study focuses on the development and validation of the Quality by Design RP\u2010HPLC method for diminazene diaceturate with fragmentation study by LC\u2013MS\/MS. The central composite design was employed to optimize critical factors: mobile phase ratio, flow rate, and wavelength. Analysis was conducted on Xterra C18 column with mobile phase composed of 0.1% triethylamine buffer: methanol (80:20% v\/v) and flow rate 0.8\u2009mL\/min at 255\u2009nm, with retention at 4.34\u2009min. ICH Q1A(R2) guidelines, acid stress degradation study showed maximum degradation of 16.03%. The fragmentation pathway exhibited prominent product ions at m\/z 518, 284, 285, and 268. Linearity was observed over the concentration range (50\u2013100\u2009\u03bcg\/mL) with a regression coefficient of 0.9997. Limit of detection and limit of quantification values were observed to be 7.772 and 23.566\u2009\u03bcg\/mL, respectively; % RSD of each parameter was found to be less than 2. The validated method proved suitable for assay of marketed veterinary formulation, yielding recovery of 93.22%, with clear separation of the stabilizer phenazone. This study focuses on the development of a stability indicating RP\u2010HPLC method using a Quality by Design approach with LC\u2013MS compatible triethylamine buffer, enabling degradation product characterization while maintaining a regulatory\u2010compliant RP\u2010HPLC method suitable for routine and stability testing of diminazene diaceturate in pharmaceutical laboratories.<\/jats:p>","DOI":"10.1002\/bmc.70428","type":"journal-article","created":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T11:01:51Z","timestamp":1773658911000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Quality by Design\u2010Based Stability\u2010Indicating RP\u2010HPLC Method for Diminazene Diaceturate in Veterinary Formulation Supported by LC\u2013MS Characterization of Degradation Products"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-2124-2663","authenticated-orcid":false,"given":"Sumedha\u00a0V.","family":"Shetye","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis Principal K. M. Kundnani College of Pharmacy  Mumbai Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3352-3567","authenticated-orcid":false,"given":"Archana\u00a0S.","family":"Gurjar","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis Principal K. M. Kundnani College of Pharmacy  Mumbai Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,3,16]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100033\u20101337939"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1155\/2017\/4269587"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0731\u20107085(02)00450\u20108"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpha.2013.09.003"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.5530\/ijper.20254323"},{"issue":"1","key":"e_1_2_6_7_1","first-page":"255","article-title":"Validation of an HPLC Method for the Simultaneous Determination of Diminazene Diaceturate and Phenazone in Injectable Veterinary Granules and Bulk Powders","volume":"25","author":"Kassaye L.","year":"2012","journal-title":"Pakistan Journal of Pharmaceutical Sciences"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2014.05.027"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.33084\/bjop"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.54328\/covm.josvas.2022.070"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2018.04.007"},{"issue":"5","key":"e_1_2_6_12_1","first-page":"1129","article-title":"Implementation of QbD & AQbD Approach in Pharmaceutical Formulation and Analytical Method Development: A Comprehensive Research Review","volume":"8","author":"Shirohiwala R.","year":"2022","journal-title":"International Journal of Advanced Research Ideas and Innovations in Technology"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/B0-12-226770-2\/01591-X"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpha.2014.07.005"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70428","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bmc.70428","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70428","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T13:32:06Z","timestamp":1776259926000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70428"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,16]]},"references-count":13,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1002\/bmc.70428"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70428","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,16]]},"assertion":[{"value":"2025-12-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70428"}}