{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T01:43:52Z","timestamp":1760060632397,"version":"build-2065373602"},"reference-count":20,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,4,2]],"date-time":"2025-04-02T00:00:00Z","timestamp":1743552000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>The present research study describes the Venetoclax (VEN)\u2010related substances test method using RP\u2010HPLC\/DAD techniques. It was developed and validated according to ICH Q14 and Q2(R2) guidelines. The substances were separated using an X\u2010Bridge Phenyl column (150\u2009mm\u2009\u00d7\u20094.6\u2009mm, 3.5\u2009\u03bcm) and a gradient program. The mobile phase A, consist 0.02\u2009mM Na2HPO4 (pH\u20098.0) buffer and acetonitrile in an 80:20\u2009v\/v ratio. Mobile phase B was prepared using a 75:25\u2009v\/v mixture of acetonitrile and a pH\u20098.0 buffer and well mixed. The flow rate remains constant at 1.0\u2009mL\/min, traversing an appropriate gradient program. The VEN and its impurities were detected at 280\u2009nm, with an injection volume of 15\u2009\u03bcL and a runtime of 130\u2009min. Moreover, we identified proper degradation impurities and sensitivity of VEN due to forced\u2010degradation study experiments. The linearity and range of the testing procedure were validated by computing <jats:italic>r<\/jats:italic><jats:sup>2<\/jats:sup> values over 0.999. All organic impurities were recovered at a rate of 97.6%\u2013106.0% with a relative standard deviation of 0.11%\u20134.35%. A robustness test was conducted utilizing the AQbD methodology. The proposed method was stability\u2010indicating in nature and can be used for commercial samples in the pharmaceutical industries.<\/jats:p>","DOI":"10.1002\/bmc.70072","type":"journal-article","created":{"date-parts":[[2025,4,2]],"date-time":"2025-04-02T20:44:31Z","timestamp":1743626671000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Quality by Design Based Chromatography Technique Development and Validation for the Medicine Venetoclax (for Chronic Leukemia), in the Context of Impurities Including Degradation Products"],"prefix":"10.1002","volume":"39","author":[{"given":"Rajeshwari","family":"Dandabattina","sequence":"first","affiliation":[{"name":"Bhavans Vivekananda College of Science, Humanities and Commerce  Secunderabad Telangana India"},{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Bengaluru Karnataka India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4647-7237","authenticated-orcid":false,"given":"Karuna\u00a0Sree","family":"Merugu","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Bengaluru Karnataka India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lova\u00a0Gani\u00a0Raju","family":"Bandaru","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Hyderabad Telangana India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9467-1061","authenticated-orcid":false,"given":"Haridasyam","family":"Sharathbabu","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Hyderabad Telangana India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0390-6505","authenticated-orcid":false,"given":"Rambabu","family":"Gundla","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Hyderabad Telangana India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"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, Westville Campus University of KwaZulu\u2010Natal  Durban South Africa"},{"name":"R&amp;D, CHEMTEX Environmental Laboratories Inc.  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