{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T21:51:53Z","timestamp":1789681913573,"version":"4.0.1"},"reference-count":24,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T00:00:00Z","timestamp":1733097600000},"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":[[2025,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Ledipasvir in combination with sofosbuvir approved by regulatory bodies used to treat chronic hepatitis C. The present work investigates the design and development of a new, quick, green, and selective UPLC (ultra\u2010performance liquid chromatography) approach to concurrently quantify sofosbuvir and ledipasvir. Optimization with Box\u2013Behnken design paired the green analytical method and quality by design\u2010based risk assessment. A mobile phase of 65%:35% ethanol by volume and phosphate buffer (15\u2009mM; pH\u20093.0) was used, with a flow rate of 0.28\u2009mL per minute, to achieve the best chromatographic separation. With linearities ranging from 20 to 100, 4.5\u201322.5\u2009\u03bcg\/mL, and <jats:italic>R<\/jats:italic><jats:sup>2<\/jats:sup> values of 0.9999 and 0.9997, respectively, the established UPLC\u2010PDA technique proved sensitive and specific for sofosbuvir and ledipasvir. The stability\u2010indicating test findings demonstrate the degradation under the relevant stress conditions. The most environmentally friendly results were found when the level of environmental sustainability was evaluated using four advanced metrics: GAPI, AES, AMGS, and AGREE. Based on the findings, we came to the conclusion that the UPLC technique that was developed would be effective for the concurrent analysis of sofosbuvir and ledipasvir in tablet medication.<\/jats:p>","DOI":"10.1002\/bmc.6047","type":"journal-article","created":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T05:45:10Z","timestamp":1733118310000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["UPLC Estimate of Sofosbuvir and Ledipasvir Utilizing Greenness Tool in Conjunction With an Analytical Quality by Design"],"prefix":"10.1002","volume":"39","author":[{"given":"Ravinder","family":"Bairam","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis Srikrupa Institute of Pharmaceutical Sciences  Siddipet India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kemmasaram","family":"Mahesh","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis Srikrupa Institute of Pharmaceutical Sciences  Siddipet India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3571-7859","authenticated-orcid":false,"given":"Hemant\u00a0Kumar","family":"Tatapudi","sequence":"additional","affiliation":[{"name":"Department of Quality Assurance, School of Pharmacy and Technology Management NMIMS  Shirpur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shruthi","family":"Thoom","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis Srikrupa Institute of Pharmaceutical Sciences  Siddipet India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.30750\/ijpbr.5.4.3"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.4103\/0976-500X.142464"},{"issue":"8","key":"e_1_2_8_4_1","first-page":"4165\u20102","article-title":"Method Development and Validation to Estimate Sofosbuvir in Marketed Preparation by UV\u2010Spectroscopy and HPLC Along With Force Degradation Study","volume":"14","author":"Bhushan A.","year":"2021","journal-title":"Research Journal of Pharmacy and Technology"},{"issue":"02","key":"e_1_2_8_5_1","first-page":"114","article-title":"Validated Ultraviolet\u2010Spectrometric Method for Determination of Sofosbuvir in Tablets Formulation","volume":"7","author":"El Hamd M. 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P.","year":"2018","journal-title":"World Journal of Pharmaceutical and Medical Research"},{"key":"e_1_2_8_8_1","volume-title":"Gilead Files for U.S. Approval of Ledipasvir\/Sofosbuvir Fixed\u2010Dose Combination Tablet for Genotype 1 Hepatitis C","author":"Gilead Sciences, Inc","year":"2014"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.19080\/JFSCI.2017.01.555562"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40543-019-0197-x"},{"key":"e_1_2_8_11_1","volume-title":"International Conference on Harmonization, Geneva, Switzerland","author":"ICH (Q2B)","year":"1996"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.4172\/1948-593X.1000224"},{"key":"e_1_2_8_13_1","first-page":"656","article-title":"Stability Indicating RP\u2010HPLC Method Development and Validation for Estimation of Sofosbuvir in Pharmaceutical Dosage Form. Pharma","volume":"1","author":"Lalitha K. 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