{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T15:52:15Z","timestamp":1791301935372,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"22","license":[{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"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":["Rapid Comm Mass Spectrometry"],"published-print":{"date-parts":[[2026,11,30]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>\n                      Acid\u2010related disorders, including gastro\u2010oesophageal reflux disease (GERD), peptic ulcers and\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Helicobacter pylori<\/jats:italic>\n                      <\/jats:styled-content>\n                      infection, affect millions worldwide. Vonoprazan fumarate, a potassium\u2010competitive acid blocker, provides rapid and sustained acid suppression. Understanding its degradation behaviour is essential for ensuring drug stability, supporting formulation development and guiding quality control.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Vonoprazan fumarate was subjected to acidic and basic hydrolysis, oxidation, thermal and photolytic stress to evaluate its degradation behaviour. Degradation products were separated by reversed\u2010phase high\u2010performance liquid chromatography (HPLC) using a gradient program optimised for mobile\u2010phase composition and flow rate, thereby enabling the chromatographic resolution of closely eluting degradation products. Structural characterisation was performed using liquid chromatography\u2013quadrupole time\u2010of\u2010flight tandem mass spectrometry (LC\u2010QTOF\u2010MS\/MS) based on accurate\u2010mass measurements and diagnostic MS\/MS dissociation patterns. The method was validated for linearity, precision, accuracy, selectivity and robustness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Nine degradation products were detected under stress conditions: Basic hydrolysis yielded degradation product (DP)\u20101 and DP\u20108; acidic stress produced DP\u20101, DP\u20102 and DP\u20104; oxidation generated DP\u20101, DP\u20102, DP\u20107 and DP\u20108; and photolysis formed DP\u20101 to DP\u20106, DP\u20108 and DP\u20109. Three degradation products exhibited identical protonated molecules and closely comparable MS\/MS dissociation patterns to the parent drug but differed in chromatographic retention times, with their relative distribution varying in solution\u2010 and solid\u2010state upon UV exposure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study provides a comprehensive evaluation of the forced degradation behaviour of vonoprazan fumarate by RP\u2010HPLC and characterisation of its degradation products using LC\u2010QTOF\u2010MS\/MS, providing insights into its degradation pathways and supporting stability assessment. Comparative solution\u2010 and solid\u2010state photostability studies revealed distinct degradation profiles, providing further insight into the photodegradation behaviour of vonoprazan fumarate.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/rcm.70170","type":"journal-article","created":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T08:11:42Z","timestamp":1788250302000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Forced Degradation Study of Vonoprazan Fumarate by HPLC and Characterisation of Its Degradation Products Using LC\u2010QTOF\u2010MS\/MS"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-7701-297X","authenticated-orcid":false,"given":"Nehal","family":"Bhatt","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis National Institute of Pharmaceutical Education and Research  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2523-094X","authenticated-orcid":false,"given":"Devendra","family":"Sonaje","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis National Institute of Pharmaceutical Education and Research  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6389-5994","authenticated-orcid":false,"given":"Gananadhamu","family":"Samanthula","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis National Institute of Pharmaceutical Education and Research  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,1]]},"reference":[{"key":"e_1_2_11_2_1","volume-title":"ICH Harmonised Tripartite Guideline Q1A(R2): Stability Testing of New Drug Substances and Products","author":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use","year":"2003"},{"key":"e_1_2_11_3_1","volume-title":"ICH Harmonised Tripartite Guideline Q1B: Photostability Testing of New Drug Substances and Products","author":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use","year":"1996"},{"key":"e_1_2_11_4_1","first-page":"227","volume-title":"WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fifty\u2010Second Report. 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