{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T05:09:27Z","timestamp":1788239367796,"version":"build-2803163510"},"reference-count":11,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2019,12,9]],"date-time":"2019-12-09T00:00:00Z","timestamp":1575849600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/501100002377","name":"Cairo University Faculty of Pharmacy","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002377","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002377","name":"Cairo University Faculty of Pharmacy","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002377","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,4,22]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Three chromatographic methods were developed, optimized and validated for Paracetamol (PAR), Orphenadrine citrate (Or.cit) and Caffeine (CAF) determination in their mixture and in presence of PAR toxic impurity; P-aminophenol (PAP) in tablets. The first method is based on a thin layer chromatography combined with densitometry. Separation was achieved using silica gel 60\u00a0F254 TLC plates and dichloromethane:methanol:acetone:glacial acetic acid (9:1:0.5:0.3, v\/v\/v) as a developing system at 230\u00a0nm. The second method is based on high-performance liquid chromatography with diode array detection. The proposed compounds are separated on a reversed phase C18 analytical column using phosphate buffer (pH\u00a09; 0.05\u00a0M) and methanol (80:20, v\/v) at 1.2\u00a0mL\/min. Linear regressions are obtained in the range of 1\u2013500\u00a0\u03bcg\/mL, 25\u20131000\u00a0\u03bcg\/mL and 1\u2013400\u00a0\u03bcg\/mL for PAR, Or.cit and CAF, respectively. Quantification of the toxic PAP is carried out using LC\u2013MS-MS by electrospray ionization in the positive mode using triple quadrupole mass spectrometry. The limit of quantification for PAP is 1\u00a0ng\/mL. All methods are validated according to the ICH guidelines and successfully applied to determine PAR, Or.cit, CAF and PAP in pure powder and in combined tablets dosage form without interference from excipients.<\/jats:p>","DOI":"10.1093\/chromsci\/bmz094","type":"journal-article","created":{"date-parts":[[2019,10,8]],"date-time":"2019-10-08T08:10:41Z","timestamp":1570522241000},"page":"223-233","source":"Crossref","is-referenced-by-count":22,"title":["Development and Validation of Chromatographic Methods for Simultaneous Determination of Paracetamol, Orphenadrine Citrate and Caffeine in Presence of P-aminophenol; Quantification of P-aminophenol Nephrotoxic Impurity Using LC\u2013MS\/MS"],"prefix":"10.1093","volume":"58","author":[{"given":"Shereen A","family":"Boltia","sequence":"first","affiliation":[{"name":"Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El\u0640Aini Street, Cairo 11562, Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aya T","family":"Soudi","sequence":"first","affiliation":[{"name":"Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El\u0640Aini Street, Cairo 11562, Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eman S","family":"Elzanfaly","sequence":"first","affiliation":[{"name":"Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El\u0640Aini Street, Cairo 11562, Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hala E","family":"Zaazaa","sequence":"first","affiliation":[{"name":"Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El\u0640Aini Street, Cairo 11562, Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,12,9]]},"reference":[{"key":"2020042308354453500_ref1","year":"2018"},{"issue":"4","key":"2020042308354453500_ref2","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1016\/j.jsps.2010.07.007","article-title":"Development of a capillary electrophoresis method for the determination of orphenadrine citrate in tablets in the presence of paracetamol","volume":"18","author":"Haj-Ali","year":"2010","journal-title":"Saudi Pharmaceutical Journal"},{"key":"2020042308354453500_ref3","volume-title":"Goodman & Gilman's the pharmacological basis of therapeutics","author":"O\u2019Brien","year":"2018","edition":"13th"},{"key":"2020042308354453500_ref4","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1016\/0041-008X(92)90372-Y","article-title":"P-aminophenol nephrotoxicity: Biosynthesis of toxic glutathione 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electrode","volume":"25","author":"Eisele","year":"2013","journal-title":"Electroanalysis"},{"key":"2020042308354453500_ref9","article-title":"Validation of analytical procedures: Methodology, ICH- Q2(R1)","volume-title":"International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use","author":"ICH","year":"2005"},{"key":"2020042308354453500_ref10","article-title":"Reviewer guidance validation of chromatographic methods","author":"FDA","year":"1994","journal-title":"Center For Drug Evaluation and Research (CDER)"},{"key":"2020042308354453500_ref11","volume-title":"Thin Layer Chromatography","author":"Fried","year":"1999","edition":"4th"}],"container-title":["Journal of Chromatographic 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