{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T21:56:11Z","timestamp":1773698171885,"version":"3.50.1"},"reference-count":32,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T00:00:00Z","timestamp":1739145600000},"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":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Clozapine is an antipsychotic medication primarily used to treat severe schizophrenia symptoms. This research aimed to develop and validate a reliable, rapid, and sensitive reverse\u2010phase high\u2010performance liquid chromatography (RP\u2010HPLC) method for measuring organic impurities in clozapine drug substances and products. The chromatographic separation was achieved using an Agilent Poroshell 120 EC\u2010C<jats:sub>18<\/jats:sub> column with gradient elution, using mobile phases consisting of acetonitrile, methanol, pH\u20092.4 phosphate buffer, and ethanol. The method operated at a flow rate of 1.0\u2009mL\/min, with a 10\u2010\u03bcL injection volume, a column temperature of 35\u00b0C, and detection at 257\u2009nm. Validation was performed according to ICH Q2(R2) guidelines and USP &lt;1225&gt; general chapter. The method demonstrated optimal resolution between adjacent peaks, with values greater than 1.5, and provided accurate estimations free from interference. Recovery and regression values ranged from 80.0% to 120.0%, with <jats:italic>R<\/jats:italic><jats:sup>2<\/jats:sup> values exceeding 0.9995. The quantification range spanned from the limit of quantification to 150% of the specification level. The stability\u2010indicating capability of the RP\u2010HPLC method was confirmed through forced degradation studies. This method has been successfully implemented in a quality control laboratory for real\u2010time analysis of clozapine drug substances and products.<\/jats:p>","DOI":"10.1002\/bmc.70021","type":"journal-article","created":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T23:23:58Z","timestamp":1739229838000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Separation and Quantitative Estimation of Pharmacopeial Organic Impurities, Process\u2010Related Impurities, and Degradation Products of the Anti\u2010Schizophrenia Drug Clozapine in Pharmaceutical Formulations by Using Stability\u2010Indicating HPLC Method"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-7035-0833","authenticated-orcid":false,"given":"Abhishek","family":"Sharma","sequence":"first","affiliation":[{"name":"Department of Chemistry, GITAM (Deemed to Be University) School of Science  Hyderabad Telangana India"},{"name":"Department of Analytical Research Biophore India Pharmaceuticals Private Limited  Hyderabad Telangana India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9555-5572","authenticated-orcid":false,"given":"Narayana\u00a0Reddy","family":"Pedavenkatagari","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM (Deemed to Be University) School of Science  Hyderabad Telangana India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bhujanga\u00a0Rao","family":"Nagulancha","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM (Deemed to Be University) School of Science  Hyderabad Telangana India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2652-5417","authenticated-orcid":false,"given":"Narasimha\u00a0Swamy","family":"Lakka","sequence":"additional","affiliation":[{"name":"Department of Analytical Research and Development AptaPharma Inc.  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