{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,5]],"date-time":"2026-07-05T21:31:49Z","timestamp":1783287109619,"version":"3.54.6"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>To assess the degradation of the drug under forced degradation, stability experiments with aspirin and pantoprazole were performed. Under the guidelines set forth by the International Conference on Harmonization, pantoprazole and aspirin were exposed to oxidation, alkaline and acidic hydrolysis and thermal stress. Under basic and acidic hydrolysis stress, the drug combination demonstrated significant degradation. Under conditions of oxidative stress and heat, however, it remained stable. A mobile phase, containing methanol: ammonium acetate buffer (0.01\u00a0M) (70: 30% v\/v) was employed, a column (250\u00a0mm\u2009\u00d7\u20094.6\u00a0mm, and 5\u00a0\u03bcm), detection wavelength was 254\u00a0nm, flow rate of 0.8\u00a0mL\u00a0min\u22121 was used. The degradation products were identified using LC\u2013MS, and fragmentation paths were suggested. (Graphical abstract: Figure 1).<\/jats:p>","DOI":"10.1093\/chromsci\/bmaf029","type":"journal-article","created":{"date-parts":[[2025,5,21]],"date-time":"2025-05-21T22:52:24Z","timestamp":1747867944000},"source":"Crossref","is-referenced-by-count":1,"title":["Stability Indicating Assay Method and LC\u2013MS Characterization of Forced Degradation Products of Pantoprazole and Aspirin"],"prefix":"10.1093","volume":"63","author":[{"given":"Tinkal S","family":"Patel","sequence":"first","affiliation":[{"name":"Gujarat Technological University , Nr. Visat Three Roads, Visat \u2013 Gandhinagar Highway, Chandkheda, Ahmedabad 382424, Gujarat ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ankit B","family":"Chaudhary","sequence":"additional","affiliation":[{"name":"Gujarat Technological University , Nr. Visat Three Roads, Visat \u2013 Gandhinagar Highway, Chandkheda, Ahmedabad 382424, Gujarat ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,5,21]]},"reference":[{"key":"2025052118521695500_ref1","first-page":"1274","volume-title":"Indian pharmacopoeia commission","author":"Indian Pharmacopoeia 2018, Government of India, Ministry of Health & Family Welfare","year":"2018"},{"key":"2025052118521695500_ref2","first-page":"1275","volume-title":"Indian pharmacopoeia commission","author":"Indian Pharmacopoeia-2018, Government of India, Ministry of Health & Family Welfare","year":"2018"},{"key":"2025052118521695500_ref3","first-page":"1276","volume-title":"Indian pharmacopoeia commission","author":"Indian Pharmacopoeia-2018Government of India, Ministry of Health & Family Welfare","year":"2018"},{"key":"2025052118521695500_ref4","first-page":"183","volume-title":"The stationery office on behalf of the medicines and healthcare products regulatory agency (MHRA)","author":"British Pharmacopoeia-2010","year":"2010"},{"key":"2025052118521695500_ref5","first-page":"1448","volume-title":"31st Revision, NF 26","author":"The United States Pharmacopoeia","year":"2008"},{"key":"2025052118521695500_ref6","first-page":"1451","volume-title":"The United States pharmacopoeia, 31st revision, NF 26","year":"2008"},{"issue":"1","key":"2025052118521695500_ref7","first-page":"389","article-title":"Analytical method development and validation for aspirin","volume":"2","author":"Kumar","year":"2010","journal-title":"International Journal of ChemTech Research"},{"issue":"6","key":"2025052118521695500_ref8","first-page":"810","article-title":"Development and validation of an alternate stability-indicating UV spectrophotometric analytical method for aspirin in tablets","volume":"78","author":"Dolores","year":"2016","journal-title":"International Journal of Pharmaceutical Science"},{"issue":"9","key":"2025052118521695500_ref9","doi-asserted-by":"crossref","first-page":"1491","DOI":"10.1093\/chromsci\/bmv043","article-title":"Isolation, characterization of a potential degradation product of aspirin and an HPLC method for quantitative estimation of its impurities","volume":"53","author":"Acharya","year":"2015","journal-title":"Journal of Chromatographic Science"},{"key":"2025052118521695500_ref10","volume-title":"Q-Absorbance ratio and chromatographic method for the analysis of aspirin and salicylic acid","author":"Osman","year":"2020"},{"issue":"1","key":"2025052118521695500_ref11","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1155\/2013\/751940","article-title":"Development and validation of RP-HPLC method for simultaneous estimation of aspirin and esomeprazole magnesium in tablet dosage form","volume":"2013","author":"Patel","year":"2013","journal-title":"Journal of Chemistry"},{"key":"2025052118521695500_ref12","first-page":"475","article-title":"Extensive study of aspirin and its related impurities under various stressed conditions in low dose aspirin and esomeprazole magnesium capsules","volume":"81","author":"Reddy","year":"2012","journal-title":"American Journal of PharmTech Research"},{"issue":"5","key":"2025052118521695500_ref13","doi-asserted-by":"crossref","first-page":"322","DOI":"10.22270\/jddt.v8i5.1825","article-title":"Rp-Hplc method development and validation for simultaneous estimation of aspirin and omeprazole in bulk and dosage form","volume":"8","author":"Sarode","year":"2018","journal-title":"Journal of Drug Delivery Therapeutics"},{"issue":"1","key":"2025052118521695500_ref14","doi-asserted-by":"crossref","first-page":"3","DOI":"10.35248\/2153-2435.20.11.618","article-title":"Development and validation of UV spectrophotometric method for the simultaneous equation of aspirin and omeprazole in tablet dosage form","volume":"11","author":"Chaudhari","year":"2020","journal-title":"Pharmaceutica Analytica Acta"},{"key":"2025052118521695500_ref15","first-page":"2848","volume-title":"Indian pharmacopoeia commission","author":"Indian Pharmacopoeia-2018, Government of India, Ministry of Health & Family Welfare","year":"2018"},{"key":"2025052118521695500_ref16","first-page":"2849","volume-title":"Indian pharmacopoeia commission","author":"Indian Pharmacopoeia-2018, Government of India, Ministry of Health & Family Welfare","year":"2018"},{"key":"2025052118521695500_ref17","first-page":"2850","volume-title":"Indian pharmacopoeia commission","author":"Indian Pharmacopoeia-2018, Government of India, Ministry of Health & Family Welfare","year":"2018"},{"key":"2025052118521695500_ref18","first-page":"1","article-title":"Development and validation of LC-MS\/MS for analyzing potential genotoxic impurities in pantoprazole starting materials","volume":"2020","author":"Chen","year":"2020","journal-title":"Journal of Analytical Methods in Chemistry"},{"issue":"1","key":"2025052118521695500_ref19","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1590\/S1984-82502013000100019","article-title":"A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations","volume":"49","author":"Pandey","year":"2013","journal-title":"Brazilian Journal of Pharmaceutical Sciences"},{"issue":"1","key":"2025052118521695500_ref20","first-page":"725","article-title":"A novel difference spectrophotometric method for the determination of pantoprazole in tablet dosage form","volume":"5","year":"2019","journal-title":"Research Journal of Life Science, Bioinformatics, Pharmaceutical and Medical Science"},{"key":"2025052118521695500_ref21","first-page":"2315","article-title":"Development and validated stability indicating rp-hplc method for the determination of pantoprazole in pure form and its tablet dosage form","volume":"8","author":"Sindhu","year":"2015","journal-title":"World Journal of Pharmaceutical Research"},{"key":"2025052118521695500_ref22","first-page":"08","article-title":"Stability-indicating RP-HPLC method development for the estimation of pantoprazole sodium in tablet dosage form","volume":"4","author":"Ali","year":"2015","journal-title":"Faraat al World Journal of Pharmacy and Pharmaceutical Science"},{"issue":"4","key":"2025052118521695500_ref23","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1556\/1326.2019.00709","article-title":"HPLC-DAD method for investigating pantoprazole for its stress-dependent degradation by photolysis and oxidation","volume":"32","author":"Bratty","year":"2020","journal-title":"Acta Chromatographica"},{"issue":"5","key":"2025052118521695500_ref24","first-page":"912","article-title":"Stability indicating HPLC-UV method for simultaneous estimation of pantoprazole, domperidone and drotaverine","volume":"8","author":"Mishra","year":"2015","journal-title":"International Journal of PharmTech Research"},{"issue":"1","key":"2025052118521695500_ref25","first-page":"34","article-title":"Selection of buffers in LC-MS\/MS: an overview","volume":"6","author":"Mannur","year":"2011","journal-title":"International Journal of Pharmaceutical Science"},{"key":"2025052118521695500_ref26","volume-title":"Guide to achieving reliable quantitative LC-MS measurements","author":"Sargent","year":"2013"},{"key":"2025052118521695500_ref27","first-page":"147\u2013160, 567\u2013587","volume-title":"Handbook of instrumental techniques for analytical chemistry","author":"Frank","year":"2004"},{"issue":"7","key":"2025052118521695500_ref28","first-page":"a","article-title":"Development, and validation of stability indicating assay development for enzalutamide in standard and dosage form by rp-hplc method","volume":"12","author":"Patel","year":"2023","journal-title":"International Journal of Biology, Pharmacy and Allied Sciences"},{"issue":"6","key":"2025052118521695500_ref29","doi-asserted-by":"crossref","first-page":"1011","DOI":"10.1016\/S0731-7085(02)00047-X","article-title":"Development of validated stability-indicating assay methods\u2014critical review","volume":"28","author":"Bakshi","year":"2002","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"issue":"6","key":"2025052118521695500_ref30","first-page":"1","article-title":"Guidance on conduct of stress tests to determine inherent stability of drugs","volume":"24","author":"Singh","year":"2002","journal-title":"Pharmaceutical Technology"},{"issue":"2","key":"2025052118521695500_ref31","first-page":"48","article-title":"Available guidance and best practices for conducting forced degradation studies","volume":"26","author":"Reynolds","year":"2002","journal-title":"Pharmaceutical Technology"}],"container-title":["Journal of Chromatographic Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/chromsci\/article-pdf\/63\/5\/bmaf029\/63266511\/bmaf029.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/chromsci\/article-pdf\/63\/5\/bmaf029\/63266511\/bmaf029.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,21]],"date-time":"2025-05-21T22:52:31Z","timestamp":1747867951000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/chromsci\/article\/doi\/10.1093\/chromsci\/bmaf029\/8140160"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5]]},"references-count":31,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5,7]]}},"URL":"https:\/\/doi.org\/10.1093\/chromsci\/bmaf029","relation":{},"ISSN":["0021-9665","1945-239X"],"issn-type":[{"value":"0021-9665","type":"print"},{"value":"1945-239X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,5]]},"published":{"date-parts":[[2025,5]]},"article-number":"bmaf029"}}