{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T17:58:18Z","timestamp":1776103098623,"version":"3.50.1"},"reference-count":23,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,1,2]],"date-time":"2025-01-02T00:00:00Z","timestamp":1735776000000},"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":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>A new selective and sensitive high\u2010performance liquid chromatography (HPLC) method was developed for the quantification of potential impurities in fluoxetine hydrochloride. Chromatographic separation was achieved on an end\u2010capped octadecylsilyl silica gel (Gemini\u2010C18 150\u2009mm\u2009\u00d7\u20094.6\u2009mm, 3.0\u2009\u03bcm) using a gradient program with triethylamine, methanol, and water as the mobile phase at a flow rate of 1.0\u2009mL\/min and monitored at 215\u2009nm. The run time was 60\u2009min. The method was validated to fulfill International Conference on Harmonization (ICH Q2(R2)) requirements, and this validation included specificity, precision, linearity, limit of detection (LOD), limit of quantification (LOQ), and accuracy. The calibration curve was linear over the concentration range from LOQ to 120% with respect to sample concentration. The accuracy of the method is within the acceptable limit of 80%\u2013120%. The results obtained for all parameters were within the acceptance criteria. So, this method can be employed for the regular analysis of potential impurities in the fluoxetine hydrochloride API.<\/jats:p>","DOI":"10.1002\/bmc.6069","type":"journal-article","created":{"date-parts":[[2025,1,3]],"date-time":"2025-01-03T00:35:52Z","timestamp":1735864552000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Characterization and Analytical Method Validation for Potential Impurities of a Merchantability Drug Substance Fluoxetine HCl"],"prefix":"10.1002","volume":"39","author":[{"given":"Rajani\u00a0Reddy\u00a0Janna","family":"Reddy","sequence":"first","affiliation":[{"name":"Department of Chemistry BEST Innovation University  Gorantla Andhra Pradesh India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8261-8880","authenticated-orcid":false,"given":"Sunder\u00a0Kumar","family":"Kolli","sequence":"additional","affiliation":[{"name":"Department of Chemistry BEST Innovation University  Gorantla Andhra Pradesh India"},{"name":"Department of Chemistry Annamacharya Institute of Technology &amp; Sciences  Hyderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0292-8545","authenticated-orcid":false,"given":"Suresh","family":"Salakolusu","sequence":"additional","affiliation":[{"name":"Analytical Discovery Chemistry Aragen Life Sciences Pvt. Ltd.  Hyderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7399-5449","authenticated-orcid":false,"given":"Sudha\u00a0Divya\u00a0Madhuri","family":"Kallam","sequence":"additional","affiliation":[{"name":"Research and Development HIKMA Pharmaceuticals  Columbus Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7313-6472","authenticated-orcid":false,"given":"Jayaprakash\u00a0Kanijam","family":"Raghupathi","sequence":"additional","affiliation":[{"name":"Department of Food Science Purdue University  West Lafayette Indiana USA"}],"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"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,1,2]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"American Society of Health\u2010System Pharmacists.2015.Fluoxetine Hydrochloride. Archived From the Original on December 8 2015."},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/0027\u20105107(95)00121\u2010X"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/0165\u20101218(88)90114\u20100"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.32383\/appdr\/89922"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2006.01.004"},{"key":"e_1_2_9_7_1","volume-title":"European Pharmacopoeia (10.3 ed.) (Monograph 01104)","author":"European Directorate for the Quality of Medicines & HealthCare","year":"2020"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1098\u20102280"},{"key":"e_1_2_9_9_1","unstructured":"Hire S. S.Aher andR.Bachhav.2023.Development and Validation of HPLC Method for Estimation of Fluoxetine HCL in Bulk and Pharmaceutical Dosage Form.https:\/\/doi.org\/10.5281\/zenodo.10065688."},{"key":"e_1_2_9_10_1","unstructured":"Indian Pharmacopoeia Commission.2021.Validation of Analytical Methods(Document ID: IPC\/GD\/04 Version 1.0)."},{"key":"e_1_2_9_11_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.2005.Validation of Analytical Procedures: Text and Methodology Q2(R1)."},{"key":"e_1_2_9_12_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.2018.Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7 (R1)."},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2017.11.039"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/00397910903422518"},{"key":"e_1_2_9_15_1","unstructured":"Mezei T.2010.Method for the Preparation of n\u2010Methyl\u2010Aryloxy\u2010Propanamine Derivatives. Wo 2010\/010412 A2."},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0731\u20107085(03)00293\u20100"},{"issue":"8","key":"e_1_2_9_17_1","first-page":"202","article-title":"A Modified Reverse Phase Liquid Chromatographic Method Development and Validation for the Fluoxetine in Bulk and Dosage Forms","volume":"4","author":"Naik R. R.","year":"2018","journal-title":"WJPMR"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/em.20485"},{"issue":"3","key":"e_1_2_9_19_1","first-page":"150","article-title":"Development and Validation of Reverse Phase HPLC Method for Determination of Ortho and Meta Isomers in N\u2010Methyl Fluoxetine Oxalate","volume":"7","author":"Tripathi U. M.","year":"2012","journal-title":"Eurasian Journal of Analytical Chemistry"},{"key":"e_1_2_9_20_1","unstructured":"U.S. Pharmacopeial Convention. n.d.Fluoxetine Hydrochloride.USPNF\u2010M33780\u201005\u201001."},{"key":"e_1_2_9_21_1","unstructured":"United States Pharmacopeial Convention.2023.Chromatography(General Chapter\u00a0621)"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.26717\/BJSTR.2021.34.005582"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/bf02496370"},{"issue":"3","key":"e_1_2_9_24_1","first-page":"44","article-title":"Development and Validation of HPTLC Method of Fluoxetine Hydrochloride in Bulk and Pharmaceutical Formulation","volume":"2","author":"Zaheer Z.","year":"2010","journal-title":"International Journal of Pharmaceutical Quality Assurance"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.6069","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T21:26:21Z","timestamp":1760045181000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.6069"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,2]]},"references-count":23,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1002\/bmc.6069"],"URL":"https:\/\/doi.org\/10.1002\/bmc.6069","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,2]]},"assertion":[{"value":"2024-10-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e6069"}}