{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T12:31:43Z","timestamp":1789129903265,"version":"build-2803163510"},"reference-count":41,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,7,12]],"date-time":"2025-07-12T00:00:00Z","timestamp":1752278400000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Separation Science"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Vildagliptin is an orally active antihyperglycemic agent used for the treatment of type 2 diabetes mellitus in adults as monotherapy either alone or in combination with metformin.\u00a0The presence of impurities in drug substances or drug products could be toxic and unsafe (injurious) to the user, and it should be ensured that drugs must be free of or controlled from any impurities to the specified level as per International Council for Harmonization guidelines before that reaches the user.\u00a0That is the reason why work on identification, isolation, and characterization of impurities in drug substances and drug products is very important towards ensuring drug safety and efficacy. Further, product\u2010related impurity isolation and characterization is an important aspect of pharmaceutical processes. The aim of the work is to identify a new impurity which was detected in vildagliptin and metformin tablets under stability storage conditions by using high\u2010performance liquid chromatography (HPLC). The new impurity was isolated and characterized by using comprehensive analysis of HPLC, flash chromatography, supercritical fluid chromatography, Fourier transform infrared spectroscopy, high\u2010resolution mass spectrometry, 1D\u2010NMR [\n                    <jats:sup>1<\/jats:sup>\n                    H and\n                    <jats:sup>13<\/jats:sup>\n                    C], and 2D\u2010NMR (\n                    <jats:sup>1<\/jats:sup>\n                    H\u2010\n                    <jats:sup>1<\/jats:sup>\n                    H correlated spectroscopy, total correlated spectroscopy,\n                    <jats:sup>1<\/jats:sup>\n                    H\u2010\n                    <jats:sup>13<\/jats:sup>\n                    C heteronuclear single quantum coherence spectroscopy,\n                    <jats:sup>1<\/jats:sup>\n                    H\u2010\n                    <jats:sup>13<\/jats:sup>\n                    C and\n                    <jats:sup>1<\/jats:sup>\n                    H\u2010\n                    <jats:sup>15<\/jats:sup>\n                    N heteronuclear multiple bond coherence spectroscopy) spectroscopic data.\n                  <\/jats:p>","DOI":"10.1002\/jssc.70218","type":"journal-article","created":{"date-parts":[[2025,7,12]],"date-time":"2025-07-12T08:22:37Z","timestamp":1752308557000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Identification, Isolation and Structural Elucidation of New Inner Salt Impurity in Vildagliptin and Metformin Tablet by Using Supercritical Fluid Chromatography, NMR, HRMS"],"prefix":"10.1002","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-0982-0371","authenticated-orcid":false,"given":"Saravana Kumar","family":"Meganathan","sequence":"first","affiliation":[{"name":"Department of Chemistry GITAM School of Science GITAM Deemed to be University  Hyderabad India"},{"name":"Natco Research Centre Natco Pharma Ltd. Industrial Estate  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0692-1567","authenticated-orcid":false,"given":"Bijaya Ketan","family":"Sahoo","sequence":"additional","affiliation":[{"name":"Department of Chemistry GITAM School of Science GITAM Deemed to be University  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-1872-0552","authenticated-orcid":false,"given":"Y. Rajender","family":"Reddy","sequence":"additional","affiliation":[{"name":"Natco Research Centre Natco Pharma Ltd. Industrial Estate  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2424-5733","authenticated-orcid":false,"given":"K.","family":"Rajani","sequence":"additional","affiliation":[{"name":"Natco Research Centre Natco Pharma Ltd. Industrial Estate  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-9712-0571","authenticated-orcid":false,"given":"Peedi Rajasekhara","family":"Reddy","sequence":"additional","affiliation":[{"name":"Natco Research Centre Natco Pharma Ltd. Industrial Estate  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,7,12]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13300\u2010010\u20100018\u20100"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102710.2011.01323.x"},{"key":"e_1_2_8_4_1","unstructured":"\u201cGalvus \u201dEuropean Medicines Agency accessed April 16 2025 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