{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T07:26:41Z","timestamp":1786692401659,"version":"build-2736575974"},"reference-count":17,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"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>\n                    An accurate and green RP\u2010HPLC stability indicating method has been developed for estimation of Imeglimin with an AQbD approach. Method optimization was done based on Box\u2013Behnken design by changing factors like mobile phase, pH, and flow rate for optimum resolution and retention time. Lean Six Sigma (DMAIC) and statistical process control techniques ensured the consistency of the method. Water\u2013methanol in the ratio of 65:35 (v\/v) adjusted to pH\u20094.0 was used as the mobile phase at a flow rate of 0.8\u2009mL\/min, having an approximate retention time of 3.7\u2009min. Method validation was performed as per the ICH guidelines, and the method exhibited a high correlation coefficient (\n                    <jats:italic>R<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    \u2009=\u20090.9994), low %RSD (&lt;\u20092%), and good accuracy (99.45%\u2013100.35%). LOD and LOQ were found to be 1.04 and 3.15\u2009\u03bcg\/mL, respectively. The results of forced degradation experiments showed significant degradation in the presence of alkaline, oxidative, and thermal stress conditions, whereas Imeglimin remained stable under photolytic stress conditions. HR\u2010MS and FTIR studies indicated that N\u2010dealkylation and N\u2010demethylation were possible degradation pathways. The greenness assessment of the developed method was carried out using AGREE, GAPI, BAGI, and CLICK indices.\n                  <\/jats:p>","DOI":"10.1002\/bmc.70563","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T09:55:41Z","timestamp":1784886941000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["AQbD\u2010Based Development and Optimization of a Stability\u2010Indicating RP\u2010HPLC Method for Imeglimin With Integration of Lean Six Sigma Principles"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0982-8747","authenticated-orcid":false,"given":"Vidhya K.","family":"Bhusari","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Chemistry, KJ'S Educational Institute Trinity College of Pharmacy  Pune Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samiksha","family":"Ghorpade","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, Smt. Kashibai Navale College of Pharmacy Savitribai Phule Pune University  Pune Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamini","family":"Sethy","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, School of Pharmacy and Life Sciences Centurion University of Technology and Management  Odisha India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,24]]},"reference":[{"key":"e_1_2_11_2_1","first-page":"675","article-title":"Development and Validation of RP\u2010HPLC Method for Pharmaceutical Analysis: A Stability\u2010Indicating Approach","volume":"14","author":"Chikhale H.","year":"2024","journal-title":"Journal of Chemical Health Risks"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14613"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261\u2010022\u201001181\u20103"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trac.2013.04.010"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0241651"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.22159\/ijap.2023v15i6.49757"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/14783363.2015.1090291"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sampre.2025.100164"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010025\u201032999\u20104"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.22270\/ajprd.v12i4.1446"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.5603\/EP.a2022.0014"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.analchem.0c01887"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1155\/2015\/868727"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463\u20101326.2012.01611.x"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dsx.2023.102710"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1155\/2020\/8768954"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/ddr.21636"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70563","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bmc.70563","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70563","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T06:30:48Z","timestamp":1786689048000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70563"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,24]]},"references-count":17,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/bmc.70563"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70563","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,24]]},"assertion":[{"value":"2026-05-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70563"}}