{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T21:18:46Z","timestamp":1775510326213,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"17","license":[{"start":{"date-parts":[[2023,7,6]],"date-time":"2023-07-06T00:00:00Z","timestamp":1688601600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Separation Science"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:p>Lumacaftor is a transmembrane conductance regulator potentiator drug, prescribed for the treatment of cystic fibrosis in patients who are homozygous for the F508del mutation. Quantitation of lumacaftor besides its degradation products and ivacaftor was achieved on a fused\u2010core silica particle column packed with pentafluorophenylpropyl stationary phase (Ascentis Express F5, 2.7\u00a0\u03bcm particle size 100\u00a0mm \u00d7 4.6\u00a0mm; Supelco) using gradient elution (A: 0.1% [<jats:italic>v\/v<\/jats:italic>] formic acid in water, B: 0.1% [<jats:italic>v\/v<\/jats:italic>] formic acid in acetonitrile [the mobile phase pH 2.5]). A constant flow rate at 1\u00a0mL\/min was applied, and the detection was realized using a photodiode array detector set at 216\u00a0nm. The pseudo tablet formulation of the lumacaftor\/ivacaftor fixed\u2010dose combination preparation, namely, Orkambi\u00ae, was prepared in vitro and used for the analytical performance validation and method application studies. In addition, five novel degradation products, four of which even have no Chemical Abstracts Services registry number, were identified using high\u2010resolution mass spectrometry instrument, and their possible mechanisms of formation were proposed. According to current literature, this paper can be regarded as the most comprehensive liquid chromatographic study on lumacaftor determination, among its counterparts.<\/jats:p>","DOI":"10.1002\/jssc.202300228","type":"journal-article","created":{"date-parts":[[2023,7,6]],"date-time":"2023-07-06T04:14:40Z","timestamp":1688616880000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Liquid chromatographic determination of lumacaftor in the presence of ivacaftor and identification of five novel degradation products using high\u2010performance liquid chromatography ion trap time\u2010of\u2010flight mass spectrometry"],"prefix":"10.1002","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5492-0457","authenticated-orcid":false,"given":"Saniye","family":"\u00d6zcan","sequence":"first","affiliation":[{"name":"Department of Analytical Chemistry Faculty of Pharmacy Anadolu University  Eskisehir T\u00fcrkiye"},{"name":"Central Analysis Laboratory Faculty of Pharmacy Anadolu University  Eski\u015fehir T\u00fcrkiye"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00dclfet","family":"Erdo\u011fan Uzuno\u011flu","sequence":"additional","affiliation":[{"name":"Department of Analytical Chemistry Faculty of Pharmacy Yeditepe University  Istanbul T\u00fcrkiye"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serkan","family":"Levent","sequence":"additional","affiliation":[{"name":"Central Analysis Laboratory Faculty of Pharmacy Anadolu University  Eski\u015fehir T\u00fcrkiye"},{"name":"Department of Pharmaceutical Chemistry Faculty of Pharmacy Anadolu University  Eskisehir T\u00fcrkiye"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0280-518X","authenticated-orcid":false,"given":"Nafiz \u00d6nc\u00fc","family":"Can","sequence":"additional","affiliation":[{"name":"Department of Analytical Chemistry Faculty of Pharmacy Anadolu University  Eskisehir T\u00fcrkiye"},{"name":"Central Analysis Laboratory Faculty of Pharmacy Anadolu University  Eski\u015fehir T\u00fcrkiye"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,7,6]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(19)30337-6"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/ppul.24823"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-016-0611-2"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13023-018-0914-3"},{"key":"e_1_2_10_6_1","doi-asserted-by":"crossref","unstructured":"PonceMF.An overview of the global pharma industry's new trends.SSRN.2019.https:\/\/doi.org\/10.2139\/ssrn.3397618","DOI":"10.2139\/ssrn.3397618"},{"key":"e_1_2_10_7_1","first-page":"748","article-title":"Pharmaceutical approval update","volume":"41","author":"Kaufman MB","year":"2016","journal-title":"Pharm Ther"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(18)30460-0"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2017.1372419"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202201061"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202200363"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1201\/b14011-12"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trac.2013.05.008"},{"key":"e_1_2_10_14_1","unstructured":"GroupIEW.ICH harmonised tripartite guideline\u2013Validation of analytical procedures text and methodology: Q2 (R1).International Conference on Harmonisation of Technical Requirements for Registrataion of Pharmaceuticals for Human Use Geneva.2005."},{"key":"e_1_2_10_15_1","article-title":"Optimized LC\u2010MS\/MS method for the high\u2010throughput analysis of clinical samples of ivacaftor, its major metabolites, and lumacaftor in biological fluids of cystic fibrosis patients","author":"Schneider EK","year":"2017","journal-title":"J Vis Exp"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2016.10.026"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.13005\/ojc\/330354"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0000000000000829"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharma.2021.11.005"},{"key":"e_1_2_10_20_1","unstructured":"ICHGuideline. 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