{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T19:56:47Z","timestamp":1773863807786,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T00:00:00Z","timestamp":1770249600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T00:00:00Z","timestamp":1770249600000},"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":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Treosulfan is a bifunctional alkylating agent widely used as a conditioning drug in haematopoietic stem cell transplantation. In this study, a robust reverse\u2010phase UPLC method was developed and validated for the quantitative determination of treosulfan and its related substances. The optimised method employed a Waters Acquity UPLC BEH shield RP\u201018 (50\u2009\u00d7\u20091.0\u2009mm, 1.7\u2009\u03bcm) column with an isocratic mobile phase of acetonitrile and ammonium acetate (pH\u20092.5)\/formic acid in a 40:60 ratio, a flow rate of 0.2\u2009mL\/min, injection volume of 5\u2009\u03bcL and detection at 239\u2009nm. Validation, performed according to ICH Q2 (R2), confirmed excellent system suitability, specificity, precision (%RSD &lt;\u20091%), linearity (\n                    <jats:italic>r<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    \u2009&gt;\u20090.999), accuracy (recoveries 99%\u2013101%) and sensitivity, with LODs and LOQs meeting acceptable criteria. Forced degradation studies under acid, alkali, oxidative, reductive, photolytic, hydrolytic and thermal conditions confirmed the method's stability\u2010indicating capability, with all purity angles below their respective purity thresholds and acceptable mass balance. LC\u2013MS\/MS analysis further enabled structural characterisation of major degradation products. Overall, the developed RP\u2010UPLC method is selective, reproducible and suitable for routine quality control and stability evaluation of treosulfan in bulk drugs.\n                  <\/jats:p>","DOI":"10.1002\/bmc.70389","type":"journal-article","created":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T06:22:34Z","timestamp":1770358954000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical Method Development and Validation of Treosulfan and Its Impurities by Ultra Performance Liquid Chromatography (UPLC) and Identification of Degradation Products by LC\u2013MS\/MS"],"prefix":"10.1002","volume":"40","author":[{"given":"Sudha\u00a0Divya\u00a0Madhuri","family":"Kallam","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Biotechnology and Pharmaceutical Sciences Vignan's Foundation for Science, Technology and Research  Guntur Andhra Pradesh India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8172-6633","authenticated-orcid":false,"given":"Mithun","family":"Rudrapal","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Biotechnology and Pharmaceutical Sciences Vignan's Foundation for Science, Technology and Research  Guntur Andhra Pradesh India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,2,5]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.202400244"},{"key":"e_1_2_8_3_1","unstructured":"Cave D. F. S. D.Gregori S.Bonanomi et\u00a0al.2022. \u201cTreosulfan Therapeutic Drug Monitoring: Optimizing Conditioning Therapy in Pediatric Hematopoietic Stem Cell Transplantation.\u201dhttp:\/\/clinicaltrials.gov\/study\/NCT06861257."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2012.10.005"},{"key":"e_1_2_8_5_1","article-title":"Forced Degradation Studies: Practical Approach\u2010Overview of Regulatory Guidance and Literature for the Drug Products and Drug Substances","volume":"1","author":"Hotha K.","year":"2013","journal-title":"Methods"},{"key":"e_1_2_8_6_1","first-page":"453","volume-title":"Clinical Applications of Mass Spectrometry in Drug Analysis: Methods and Protocols","author":"Hutcherson S. 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