{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T19:21:29Z","timestamp":1740165689623,"version":"3.37.3"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2021,5,29]],"date-time":"2021-05-29T00:00:00Z","timestamp":1622246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Taif University Researchers Supporting Project","award":["TURSP-2020\/56"],"award-info":[{"award-number":["TURSP-2020\/56"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Diflunisal (DIF) has analgesic and anti-inflammatory activity. It is a pharmacopeial drug found in the British Pharmacopoeia (BP), and its major pharmacopeial impurity is biphenyl-4-ol (BPL).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>DIF has not previously been determined together with BPL. The presence of BPL could significantly affect the dose of DIF in its dosage forms; hence it is crucial to determine DIF and BPL in each other\u2019s presence.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>TLC is the first proposed method, where DIF and BPL were separated on silica gel TLC F254 plates. The eluent was toluene\u2013acetone\u2013acetic acid solution (3.5:6.5:1, v\/v). Reversed-phase (RP) HPLC is the second suggested method, where a mixture of DIF and BPL was separated on a C18 (5\u2009\u00b5m ps, 250\u2009mm and 4.6 id) column using phosphate buffer pH 4 (0.05\u2009M)\u2013acetonitrile (40:60, v\/v). Detection was carried out at 254\u2009nm in both methods.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>For the TLC method, concentration ranges of 0.5\u20133 and 0.3\u20131.7\u2009\u00b5g\/band were used, with mean percentage recoveries of 100.22% (SD 0.893) and 100.52% (SD 0.952) for DIF and BPL, respectively. The RP-HPLC method was carried out over a concentration range of 5\u201330 and 2\u20139\u2009\u03bcg\/mL, with mean percentage recoveries of 100.10% (SD 1.259) and 98.88% (SD 0.822) for DIF and BPL, respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The TLC and RP-HPLC methods were successfully applied for the determination of DIF and BPL, quantitatively, whether in bulk powder or in pharmaceutical formulations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Highlights<\/jats:title>\n                  <jats:p>Two chromatographic methods were developed and validated according to International Council on Harmonization guidelines for the assay of DIF and its pharmacopeial impurity.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jaoacint\/qsab076","type":"journal-article","created":{"date-parts":[[2021,5,28]],"date-time":"2021-05-28T19:18:27Z","timestamp":1622229507000},"page":"1719-1725","source":"Crossref","is-referenced-by-count":3,"title":["Separation and Determination of Diflunisal and its Impurity by Two Chromatographic Methods: TLC\u2013Densitometry and HPLC"],"prefix":"10.1093","volume":"104","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7145-565X","authenticated-orcid":false,"given":"Nehal F","family":"Farid","sequence":"first","affiliation":[{"name":"Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St, Beni-Suef, 62514, Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5867-1868","authenticated-orcid":false,"given":"Ibrahim A","family":"Naguib","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O. Box 11099, Taif, 21944, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0130-4594","authenticated-orcid":false,"given":"Radwa S","family":"Moatamed","sequence":"additional","affiliation":[{"name":"National Organization for Drug Control and Research (NODCAR), Giza, Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0383-2091","authenticated-orcid":false,"given":"Mohamed R","family":"El Ghobashy","sequence":"additional","affiliation":[{"name":"Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt"},{"name":"Analytical Chemistry Department, Faculty of Pharmacy, October 6 University, Giza, Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,5,29]]},"reference":[{"volume-title":"British Pharmacopoeia","year":"2013","first-page":"2606","key":"2021121116234440400_qsab076-B1"},{"key":"2021121116234440400_qsab076-B2","first-page":"44","volume-title":"Martindale \u2013The Complete Drug Reference","author":"Sweetman","year":"2009","edition":"36th Ed"},{"year":"2021","key":"2021121116234440400_qsab076-B3"},{"year":"2005","key":"2021121116234440400_qsab076-B4"},{"key":"2021121116234440400_qsab076-B5","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1016\/S0378-4347(00)82620-1","volume":"495","author":"Streete","year":"1989","journal-title":"J. Chromatogr. B"},{"key":"2021121116234440400_qsab076-B6","doi-asserted-by":"crossref","first-page":"712","DOI":"10.1097\/00007691-198911000-00018","volume":"11","author":"Dickinson","year":"1989","journal-title":"Ther. Drug Monit."},{"key":"2021121116234440400_qsab076-B7","first-page":"47","volume":"40","author":"El-Saharty","year":"2002","journal-title":"Bull. Fac. Pharm. Cairo Univ"},{"key":"2021121116234440400_qsab076-B8","doi-asserted-by":"crossref","first-page":"872","DOI":"10.1093\/chromsci\/bms181","volume":"51","author":"Patel","year":"2013","journal-title":"J. Chromatogr. Sci."},{"key":"2021121116234440400_qsab076-B9","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1016\/0378-4347(87)80159-7","volume":"420","author":"Moller","year":"1987","journal-title":"J. Chromatogr. B"},{"key":"2021121116234440400_qsab076-B10","first-page":"8","volume":"22","author":"Wahbi","year":"2009","journal-title":"Pak. J. Pharm. Sci"},{"key":"2021121116234440400_qsab076-B11","doi-asserted-by":"crossref","first-page":"713","DOI":"10.3797\/scipharm.1301-24","volume":"81","author":"Shaalan","year":"2013","journal-title":"Sci. Pharm"},{"key":"2021121116234440400_qsab076-B12","doi-asserted-by":"crossref","first-page":"663","DOI":"10.1016\/S0731-7085(99)00039-4","volume":"20","author":"Bebawy","year":"1999","journal-title":"J. Pharm. Biomed. Anal."},{"key":"2021121116234440400_qsab076-B13","doi-asserted-by":"crossref","first-page":"26","DOI":"10.15272\/ajbps.v4i30.447","volume":"4","author":"Abdelwahab","year":"2014","journal-title":"Asian J. Biomed. Pharm. Sci"},{"key":"2021121116234440400_qsab076-B14","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1016\/S0379-0738(99)00106-1","volume":"105","author":"El Haj","year":"1999","journal-title":"Forensic Sci. Int."},{"key":"2021121116234440400_qsab076-B15","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1016\/0003-2670(94)00415-I","volume":"300","author":"Ioannou","year":"1995","journal-title":"Anal. Chim. Acta"},{"key":"2021121116234440400_qsab076-B16","doi-asserted-by":"crossref","first-page":"55","DOI":"10.1016\/j.aca.2006.10.009","volume":"583","author":"Murillo","year":"2007","journal-title":"Anal. Chim. Acta"},{"key":"2021121116234440400_qsab076-B17","doi-asserted-by":"crossref","first-page":"949","DOI":"10.1366\/000370210792081055","volume":"64","author":"Pulgarin","year":"2010","journal-title":"Appl. Spectrosc."},{"key":"2021121116234440400_qsab076-B18","volume-title":"HPTLC: High Performance Thin Layer Chromatography: Quantitative Analysis of Drugs in Pharmaceutical Formulations","author":"Sethi","year":"1996","edition":"2nd Ed."},{"volume-title":"Validation of Analytical Procedures: Text and Methodology Q2 (R1)","year":"2005","key":"2021121116234440400_qsab076-B19"},{"key":"2021121116234440400_qsab076-B20","first-page":"11","volume-title":"Thin Layer Chromatography, Chromatographic Science Series","author":"Fried","year":"1999"},{"volume-title":"U.S. Pharmacopeia (USP34) National Formulary (NF29)","year":"2011","first-page":"780","key":"2021121116234440400_qsab076-B21"}],"container-title":["Journal of AOAC INTERNATIONAL"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/jaoac\/advance-article-pdf\/doi\/10.1093\/jaoacint\/qsab076\/40394779\/qsab076.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jaoac\/article-pdf\/104\/6\/1719\/41726481\/qsab076.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jaoac\/article-pdf\/104\/6\/1719\/41726481\/qsab076.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,11]],"date-time":"2021-12-11T16:24:19Z","timestamp":1639239859000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jaoac\/article\/104\/6\/1719\/6288492"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,29]]},"references-count":21,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,5,29]]},"published-print":{"date-parts":[[2021,12,11]]}},"URL":"https:\/\/doi.org\/10.1093\/jaoacint\/qsab076","relation":{},"ISSN":["1060-3271","1944-7922"],"issn-type":[{"type":"print","value":"1060-3271"},{"type":"electronic","value":"1944-7922"}],"subject":[],"published-other":{"date-parts":[[2021,12,1]]},"published":{"date-parts":[[2021,5,29]]}}}