{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T07:26:42Z","timestamp":1786692402859,"version":"build-2736575974"},"reference-count":27,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T00:00:00Z","timestamp":1785974400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T00:00:00Z","timestamp":1785974400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Cystic fibrosis, a genetic disorder caused by mutations in the CFTR gene, is commonly treated using combination therapy with IVA and LUMA. Accurate quantification of these drugs in human plasma is essential for therapeutic monitoring; however, conventional analytical methods often lack sufficient sensitivity and robustness. In this study, a QbD\u2010based RP\u2010UPLC method was developed and validated for the simultaneous estimation of IVA and LUMA in human plasma. The primary objective was to achieve efficient separation of analytes from plasma interferences with reduced run time and consistent analytical performance. Chromatographic separation was carried out using a Waters Acquity UPLC system equipped with a CSH C18 column (100\u2009mm\u2009\u00d7\u20092.1\u2009mm, 1.8\u2009\u03bcm). Method optimization was performed using a Central Composite Design model. The mobile phase is 0.01\u2009N ammonium acetate and acetonitrile (60:40, v\/v) at a flow rate of 0.3\u2009mL\/min, with the column maintained at 30\u00b0C. EMT was used as the internal standard, and detection was conducted at 260\u2009nm. The retention times were 1.45, 1.77, and 1.99\u2009min for EMT, IVA, and LUMA, respectively. The method is reliable, rapid and selective, exhibiting excellent linearity, precision, and accuracy, complying with USFDA guidelines.<\/jats:p>","DOI":"10.1002\/bmc.70587","type":"journal-article","created":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T23:58:09Z","timestamp":1786060689000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["An Integrated Quality by Design RP\u2010UPLC Method for Lumacaftor and Ivacaftor in Human Plasma"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6984-2423","authenticated-orcid":false,"given":"Subbarao","family":"Jhampani","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Chemistry Chebrolu Hanumaiah Institute of Pharmaceutical Sciences  Chowdavaram Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1219-2954","authenticated-orcid":false,"given":"Rayini Venkata sai","family":"Mounica","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis University College of Pharmaceutical Sciences Acharya Nagarjuna University  Guntur Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8804-8003","authenticated-orcid":false,"given":"Suryadevara","family":"Vidhyadhara","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics Chebrolu Hanumaiah Institute of Pharmaceutical Sciences  Chowdavaram Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,6]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.13005\/ojc\/330354"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/arm92040026"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.21276\/ijpbs.2019.9.3.143"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.33545\/26646862.2024.v6.i1a.44"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.13005\/ojc\/370411"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2019.00020"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpan.2025.03.006"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/s43094\u2010021\u201000254\u2010y"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10337\u2010013\u20102477\u20108"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2021.577263"},{"key":"e_1_2_10_12_1","unstructured":"Huesgen A. G. andE.Naegele.2009. \u201cAutomated Alternating Column Regeneration on the Agilent 1290 Infinity LC (Publication No. 5990\u20105069EN) Agilent Technologies.\u201d"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.36673\/IJRPNS.2020.v09.i01.A01"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.22159\/ijpps.2020v12i9.38412"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00216\u2010020\u201002821\u20103"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2020.01096"},{"key":"e_1_2_10_17_1","unstructured":"National Center for Biotechnology Information.2026. \u201cPubChem Compound Summary for CID 16678941 Lumacaftor.\u201dhttps:\/\/pubchem.ncbi.nlm.nih.gov\/compound\/Lumacaftor."},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.55971\/EJLS.1367996"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.5958\/2231-5675.2020.00005.8"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-815799-2.00005-8"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2016.08.006"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1183\/23120541.00495\u20102022"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.20959\/wjpps20221\u201020833"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.5958\/0974\u2010360X.2020.00284.X"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1159\/000377638"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1186\/s43094\u2010021\u201000396\u2010z"},{"key":"e_1_2_10_27_1","unstructured":"US Department of Health and Human Services.2001. \u201cGuidance for Industry Bioanalytical Method Validation.\u201d"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.31032\/IJBPAS\/2024\/13.11.8391"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70587","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bmc.70587","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70587","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T06:30:54Z","timestamp":1786689054000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70587"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,6]]},"references-count":27,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/bmc.70587"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70587","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,6]]},"assertion":[{"value":"2026-04-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70587"}}