{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T03:32:24Z","timestamp":1781753544511,"version":"3.54.5"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"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":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The purpose of this research was to establish and validate a reverse phase HPLC method for the determination of Elagolix impurities in pharmaceutical dosage form. Mobile phase A, consisting of 10\u00a0mM sodium dihydrogen phosphate (pH\u00a06.0) and acetonitrile in a 95:5\u00a0v\/v ratio, and mobile phase B, containing 85:10:5\u00a0v\/v\/v of acetonitrile, Milli\u2010Q water, and methanol, were used to achieve the method's specificity in the analytical column Kromasil 100\u2010C18 (250\u2009mm\u2009\u00d7\u20094.6\u00a0mm, 5\u00a0\u03bcm). The gradient program includes (%B\/Time [min]: 36\/0, 36\/10, 38\/15, 85\/55, 85\/65, 36\/67, and 36\/75). The flow rate is 0.8\u00a0mL\/min. The overall run duration is 75.0\u00a0min, the injection volume is 10.0\u00a0\u03bcL, and the detection is at 210\u2009nm in UV. The samples were subjected to hydrolysis, oxidation, and heat conditions in order to facilitate their forced degradation. The procedure was validated and determined with the standards of ICH guidelines. From the LOQ to a concentration level of 200%, the linearity of the technique was ascertained. An accuracy range of LOQ to 150% was established for the method, and the average recovery was acceptable. Design of experiments, part of the quality by design idea, was used to prove the method's reliability.<\/jats:p>","DOI":"10.1002\/bmc.6036","type":"journal-article","created":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T03:53:39Z","timestamp":1730433219000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Stability indicating RP\u2010HPLC method development and validation for quantification of impurities in gonadotropin\u2010releasing hormone (Elagolix): Robustness study by quality by design"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-7154-9331","authenticated-orcid":false,"given":"Lova Gani Raju","family":"Bandaru","sequence":"first","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Hyderabad Telanga India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3039-7737","authenticated-orcid":false,"given":"Phani Raja","family":"Kanuparthy","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Hyderabad Telanga India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4686-2493","authenticated-orcid":false,"given":"Nagalakshmi","family":"Jeedimalla","sequence":"additional","affiliation":[{"name":"Laurus Generics, Inc.  Berkeley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7023-4553","authenticated-orcid":false,"given":"Bhukya Vijay","family":"Nayak","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, GITAM School of Pharmacy GITAM Deemed to be University  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7313-6472","authenticated-orcid":false,"given":"Jayaprakash Kanijam","family":"Raghupathi","sequence":"additional","affiliation":[{"name":"Department of Food Science Purdue University  West Lafayette Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5737-8528","authenticated-orcid":false,"given":"Naresh Kumar","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":[{"vocabulary":"crossref","role":"author"}]},{"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 Telanga India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,11]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5805"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.greeac.2023.100090"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/jaoacint\/qsad019"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2023.123677"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.2217\/WHE.14.68"},{"key":"e_1_2_9_7_1","unstructured":"ICH Guidelines stability testing of new drug substances and products. 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