{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T17:00:41Z","timestamp":1787763641546,"version":"build-2784847793"},"reference-count":49,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T00:00:00Z","timestamp":1707782400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001501","name":"University Grants Commission","doi-asserted-by":"publisher","award":["36\/N\/296"],"award-info":[{"award-number":["36\/N\/296"]}],"id":[{"id":"10.13039\/501100001501","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Rapid Comm Mass Spectrometry"],"published-print":{"date-parts":[[2024,4,15]]},"abstract":"<jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>\n                      Azelastine HCl is a second\u2010generation H\n                      <jats:sub>1<\/jats:sub>\n                      \u2010receptor antagonist approved by the US Food and Drug Administration (US FDA) for treating seasonal allergic rhinitis and non\u2010allergic vasomotor rhinitis. This study encompasses the validation of a liquid chromatography\u2010ultra violet photo diode array (LC\u2010UV\/PDA) method for the drug and its extension to liquid chromatography\/quadrupole time\u2010of\u2010flight\u00a0\n                      <jats:bold>mass<\/jats:bold>\n                      \u00a0spectrometry (LC\u2010Q\/TOF\u2010MS) studies for identification and characterization of various stress degradation products of the drug.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Stress degradation of azelastine HCl was undertaken under the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) prescribed conditions of hydrolytic, photolytic, oxidative, and thermal stress. The degraded drug solutions were analyzed using Ultra Performance Liquid Chromatography (UPLC) employing a C18 (100\u2009\u00d7\u20094.6\u00a0mm; 2.6\u00a0\u03bc, Kinetex) column by isocratic elution. Detection wavelength was 241\u2009nm. The degradation products were identified and characterized using UPLC\u2010MS\/TOF studies, and an attempt was made to isolate one of the degradation products by solvent extraction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The drug was found to significantly degrade under acidic\/alkaline\/neutral photolytic, oxidative, and alkaline hydrolytic conditions. Six degradation products (\n                      <jats:bold>I\u2013VI<\/jats:bold>\n                      ) were identified through LC\u2010Q\/TOF\u2010MS studies that were adequately resolved from the drug with the developed UPLC method. All degradation products (\n                      <jats:bold>I\u2013VI<\/jats:bold>\n                      ) were ionized in the total ion chromatogram (TIC) in the LC\u2010MS studies, and these were identified and characterized, and the degradation pathway of the drug was postulated. One of the oxidation products isolated from the degraded drug solution was characterized through differential scanning calorimetry, Fourier\u2010transform infrared spectroscopy, and nuclear magnetic resonance spectral data.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Six degradation products generated from stress degradation studies on azelastine HCl were adequately resolved through LC\u2010UV\/PDA studies followed by method validation. These were successfully identified and characterized through LC\u2010Q\/TOF\u2010MS studies, and the degradation pathways for the generation of these products from the drug have been postulated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/rcm.9712","type":"journal-article","created":{"date-parts":[[2024,2,14]],"date-time":"2024-02-14T01:35:11Z","timestamp":1707874511000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Method validation and characterization of stress degradation products of azelastine hydrochloride using LC\u2010UV\/PDA and LC\u2010Q\/TOF\u2010MS studies"],"prefix":"10.1002","volume":"38","author":[{"given":"Sudhanshu","family":"Shekhar","sequence":"first","affiliation":[{"name":"University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study Panjab University  Chandigarh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8034-3518","authenticated-orcid":false,"given":"Alka","family":"Bali","sequence":"additional","affiliation":[{"name":"University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study Panjab University  Chandigarh India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,2,13]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/WAO.0b013e318196ca1e"},{"key":"e_1_2_15_3_1","unstructured":"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2012\/020114s023lbl.pdf"},{"issue":"10","key":"e_1_2_15_4_1","first-page":"2441","article-title":"Azelastine hydrochloride: a review of pharmacology, pharmacokinetics, clinical efficacy and tolerability","volume":"23","author":"Bernstein JA","journal-title":"Expert Opin Pharmacother"},{"key":"e_1_2_15_5_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.8.5.701"},{"key":"e_1_2_15_6_1","doi-asserted-by":"publisher","DOI":"10.2174\/1573411014666180727130722"},{"key":"e_1_2_15_7_1","doi-asserted-by":"publisher","DOI":"10.19080\/JFSCI.2017.01.555565"},{"issue":"2","key":"e_1_2_15_8_1","first-page":"48","article-title":"Determination of azelastine hydrochloride and benzalkonium chloride in their ophthalmic solution by different spectrophotometric methods","volume":"2","author":"Hassouna MEM","year":"2017","journal-title":"World"},{"issue":"2","key":"e_1_2_15_9_1","first-page":"62","article-title":"RP\u2010HPLC determination of azelastine in pure and in ophthalmic formulation","volume":"17","author":"Boovizhikannan T","year":"2012","journal-title":"Int J Pharm Sci Rev Res"},{"key":"e_1_2_15_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13765\u2010015\u20100004\u20103"},{"key":"e_1_2_15_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.3298"},{"issue":"2","key":"e_1_2_15_12_1","first-page":"389","article-title":"Simultaneous enantioselective separation of azelastine and three of its metabolites for the investigation of the enantiomeric metabolism in rats: I. 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