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MDS softgel capsule samples were subjected to stress testing per International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines for impurity profiling study. MDS underwent extensive degradation under stress testing (acid, alkaline, oxidative, photolytic, thermolytic, and hydrolysis conditions) and formed four degradation products (DPs). MDS and its DPs were separated well from one another with good resolution using reserved\u2010phase HPLC using an Inertsil ODS\u20103V column (250\u2009\u00d7\u20094.6\u00a0mm, 5\u00a0\u03bcm) and a mobile phase of ammonium formate (40\u2009mM) and acetonitrile. The stability\u2010indicating characteristic of the newly developed method was proven for the estimation of MDS assay, and its organic impurities were free from interference. The validated method exhibited excellent linearity, accuracy, precision, specificity, detection limit, and quantitation limit within 25 min run time. Stress testing, robustness, and solution stability were performed to ensure the continuous performance of the developed method. The peak fractions of DPs formed under stress testing were isolated and characterized using LC\u2013MS, <jats:sup>1<\/jats:sup>H and <jats:sup>13<\/jats:sup>C NMR, IR, and UV\u2013Vis. The structure of the major DPs was predicted as DP1 based on the spectral data. The proposed method is effectively used for MDS in bulk drug and finished formulations in the pharmaceutical industry.<\/jats:p>","DOI":"10.1002\/bmc.5222","type":"journal-article","created":{"date-parts":[[2021,7,31]],"date-time":"2021-07-31T07:14:52Z","timestamp":1627715692000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Impurity profiling and stability\u2010indicating method development and validation for the estimation of assay and degradation impurities of midostaurin in softgel capsules using HPLC and LC\u2013MS"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2952-7493","authenticated-orcid":false,"given":"Narasimha Swamy","family":"Lakka","sequence":"first","affiliation":[{"name":"Division of Chemistry, Department of Science and Humanities VIGNAN'S Foundation for Science, Technology and Research (VFSTR)  Vadlamudi Guntur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3780-6222","authenticated-orcid":false,"given":"Chandrasekar","family":"Kuppan","sequence":"additional","affiliation":[{"name":"Division of Chemistry, Department of Science and Humanities VIGNAN'S Foundation for Science, Technology and Research (VFSTR)  Vadlamudi Guntur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Poornima","family":"Ravinathan","sequence":"additional","affiliation":[{"name":"Department of Science and Humanities JMJ College for Women  Tenali India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,9,8]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.37285\/ijpsn.2018.11.6.4"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.22270\/jddt.v10i2-s.4040"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpha.2013.09.003"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2013.07.013"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/0960-894X(94)80004-9"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.116.072744"},{"key":"e_1_2_8_8_1","unstructured":"ICH. 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