{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T14:56:43Z","timestamp":1787497003475,"version":"build-2736575974"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2022,9,19]],"date-time":"2022-09-19T00:00:00Z","timestamp":1663545600000},"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":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Midostaurin (MTN), designated as an orphan medicinal product, is emerging as an important drug for treating acute myeloid leukemia and advanced systematic mastocytosis. The proposed method was developed and validated to evaluate the related impurities of MTN. The impurities were separated using a YMC Trait C18 ExRS column (150\u2009\u00d7\u20094.6\u00a0mm, 3\u00a0\u03bcm). Mobile phase A consisted of a 10\u2010mM concentration of phosphate buffer adjusted to pH\u00a03.0 with diluted orthophosphoric acid, and mobile phase B consisted of 90% acetonitrile and 10% water. The optimized chromatographic conditions were as follows: flow rate, 0.5\u00a0mL\u2009min\n                    <jats:sup>\u22121<\/jats:sup>\n                    ; injection volume, 10\u00a0\u03bcL; UV detection, 290\u2009nm; and linear gradient program, up to 65\u2009min. The method was developed using an analytical quality by design approach. A systematic flow chart shows the evaluation, control, and life cycle management method. As part of method evaluation, risk assessment was conducted. The method has been validated per current guidelines of the International Conference on Harmonization. The recovery study and linearity ranges were established from the limit of quantification to 150% optimal concentrations. The recovery was found to be between 95.5 and 102.5%, and linearity (\n                    <jats:italic>r<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    ) was 0.9998\u20130.9999 for all the identified impurities. The method precision results were achieved below 10% of relative standard deviation. Forced degradation studies were performed under chemical and physical stress conditions. The compound was sensitive to chemical stress conditions. During the study, the analyte degraded and was converted into the identified degradation impurities, and its molecular mass was found using the LC\u2013MS technique.\n                  <\/jats:p>","DOI":"10.1002\/bmc.5486","type":"journal-article","created":{"date-parts":[[2022,8,24]],"date-time":"2022-08-24T12:28:26Z","timestamp":1661344106000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Development and validation of novel RP\u2010HPLC method for midostaurin determination using analytical quality by design approach from regulatory perspective and determination of major degradation compounds of midostaurin using LC\u2013MS"],"prefix":"10.1002","volume":"36","author":[{"given":"Madhu Prakash","family":"Reddy Saddala","sequence":"first","affiliation":[{"name":"Department of Chemistry, School of Science GITAM (Deemed to Be University) Hyderabad  Sangareddy India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0815-9238","authenticated-orcid":false,"given":"Naresh","family":"Konduru","sequence":"additional","affiliation":[{"name":"Analytical Research and Development Zhuhai Resproly Pharmaceutical Technology Co., Ltd  Zhuhai City China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0390-6505","authenticated-orcid":false,"given":"Rambabu","family":"Gundla","sequence":"additional","affiliation":[{"name":"Department of Chemistry, School of Science GITAM (Deemed to Be University) Hyderabad  Sangareddy India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1199-2458","authenticated-orcid":false,"given":"Leela Prasad","family":"Kowtharapu","sequence":"additional","affiliation":[{"name":"Analytical Development WUXI STA (Wuxi app Tec Company) Pharmaceutical Co., Ltd  Wuxi China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,9,19]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.37285\/ijpsn.2018.11.6.4"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2013.11.003"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V120.21.4913.4913"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.21203\/rs.3.pex-880\/v2"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.52711\/2231-5675.2022.00013"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.116.072744"},{"key":"e_1_2_7_8_1","unstructured":"ICH Harmonized Tripartite Guideline. (2005).Validation of analytical procedures: Text and methodology Q2 (R1)."},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.202100063"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/22297928.2019.1673814"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5359"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202100979"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/jaoacint\/qsac072"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5222"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5170"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.26452\/ijrps.v11i4.3114"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.4169"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5244"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.202000029"},{"key":"e_1_2_7_20_1","unstructured":"Thakekar S. Fegade B. Jadhav M. Munipalli V. K. Singh R. M. &Bhaskar V.(2021). Development and validation of reverse phase high performance liquid chromatographic method for quantitative estimation of idostaurin in Capsule Dosage Form."},{"key":"e_1_2_7_21_1","volume-title":"United States Pharmacopeial convention","author":"USP 43 NF 38 General Chapters: <1225> Validation of compendial procedures","year":"2020"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.5486","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bmc.5486","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.5486","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T20:50:28Z","timestamp":1760043028000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.5486"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,19]]},"references-count":20,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["10.1002\/bmc.5486"],"URL":"https:\/\/doi.org\/10.1002\/bmc.5486","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,19]]},"assertion":[{"value":"2022-05-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e5486"}}