{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T19:42:05Z","timestamp":1793821325333,"version":"4.6.1"},"reference-count":21,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"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":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>An AQbD\u2010based approach was employed to develop and validate a reliable, stability\u2010indicating RP\u2010HPLC method for quantifying sotagliflozin in API and tablet dosage forms. Sotagliflozin, a dual SGLT\u20101\/2 inhibitor used in diabetes management and cardiovascular risk reduction, requires a sensitive and robust analytical method for quality control and stability assessment. Critical method parameters were screened using a Taguchi design and optimized through Box\u2013Behnken Design (BBD). Chromatographic separation was achieved on an Agilent Zorbax SB\u2010C18 column using an eco\u2010friendly mobile phase comprising ethanol and 0.1% TFA (pH\u20092.25) in a 38:62% v\/v ratio at a flow rate of 1\u2009mL\/min, yielding excellent system performance. The method was validated according to ICH guidelines, demonstrating good linearity (25\u2013150\u2009\u03bcg\/mL), precision, accuracy, robustness, and sensitivity with low LOD and LOQ values. Forced degradation studies confirmed its stability\u2010indicating capability, with notable degradation under acidic (11.03%), alkaline (14.13%), oxidative (12.39%), and thermal (14.49%) conditions, while minimal degradation occurred under hydrolytic and photolytic stress. LC\u2013MS\/MS enabled identification and structural characterization of four major degradation products. Greenness assessment using AGREE and MoGAPI tools yielded scores of 0.89 and 91, respectively, confirming the method's eco\u2010friendly nature for routine pharmaceutical analysis.<\/jats:p>","DOI":"10.1002\/bmc.70597","type":"journal-article","created":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:26:38Z","timestamp":1787012798000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["QbD\u2010Assisted RP\u2010HPLC Method Development and Validation for the Quantification of Sotagliflozin With LC\u2013MS\/MS Characterization of Its Degradation Products and Greenness Assessment Using AGREE and MoGAPI"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-5747-0876","authenticated-orcid":false,"given":"Ankit","family":"Gupta","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Pharmaceutical Sciences Babasaheb Bhimrao Ambedkar University  Lucknow Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-6481-3410","authenticated-orcid":false,"given":"Akash","family":"Sharma","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Pharmaceutical Sciences Babasaheb Bhimrao Ambedkar University  Lucknow Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gudiya","family":"Devi","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Pharmaceutical Sciences Babasaheb Bhimrao Ambedkar University  Lucknow Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-5030-1903","authenticated-orcid":false,"given":"Chimpiri","family":"Srujani","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Pharmaceutical Sciences Babasaheb Bhimrao Ambedkar University  Lucknow Uttar Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-0766-4713","authenticated-orcid":false,"given":"Aswin","family":"Viswanath","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences Lovely Professional University  Phagwara Punjab India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9431-2096","authenticated-orcid":false,"given":"Desavathu","family":"Madhuri","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Central University of Rajasthan  Ajmer Rajasthan India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mastanamma","family":"Shaik","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, College of Pharmaceutical Sciences Acharya Nagarjuna University  Guntur Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,17]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.20944\/preprints202409.0057.v1"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0025\u20107753(13)70062\u20109"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/S12933\u2010019\u20100828\u2010Y\/FIGURES\/5"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.13005\/OJC\/410238"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsps.2018.07.011"},{"key":"e_1_2_10_7_1","volume-title":"Drug Trials Snapshots: INPEFA|FDA","author":"FDA","year":"2024"},{"key":"e_1_2_10_8_1","volume-title":"Inhibitors of Sodium Glucose Co\u2010Transporter 2 and Methods of Their Use (Patent US7,781,577B2)","author":"Harrison B. 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