Development and validation of impurity-profiling UPLC method for the determination of sodium cromoglicate and tetryzoline hydrochloride: Application on rabbit aqueous humor

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dc.AffiliationOctober University for modern sciences and Arts (MSA)
dc.contributor.authorLotfy H.M.
dc.contributor.authorSaleh S.S.
dc.contributor.authorHassan N.Y.
dc.contributor.authorSalem H.
dc.contributor.otherAnalytical Chemistry Department
dc.contributor.otherFaculty of Pharmacy
dc.contributor.otherCairo University
dc.contributor.otherKasr-El Aini
dc.contributor.otherCairo
dc.contributor.other11562
dc.contributor.otherEgypt; Pharmaceutical Chemistry department
dc.contributor.otherFaculty of Pharmaceutical sciences and Pharmaceutical industries
dc.contributor.otherFuture University in Egypt (FUE)
dc.contributor.otherCairo
dc.contributor.other12311
dc.contributor.otherEgypt; Analytical Chemistry Department
dc.contributor.otherFaculty of Pharmacy
dc.contributor.otherOctober University for Modern Sciences and Arts (MSA)
dc.contributor.other6th October
dc.contributor.other11787
dc.contributor.otherEgypt; Analytical Chemistry Department
dc.contributor.otherFaculty of Pharmacy
dc.contributor.otherDeraya University
dc.contributor.otherMinia
dc.contributor.otherEgypt
dc.date.accessioned2020-01-09T20:41:44Z
dc.date.available2020-01-09T20:41:44Z
dc.date.issued2015
dc.descriptionScopus
dc.descriptionMSA Google Scholar
dc.description.abstractSodium cromoglicate (SCG), antihistaminic agent, and tetryzoline hydrochloride (TZH), a sympathomimetic agent, are formulated together as an ophthalmic preparation. An ultra-performance liquid chromatographic method with UV detection (UPLC-UV) was developed and validated for the quantitative determination of SCG and TZH in rabbit aqueous humor. Due to the instability of both SCG and TZH under alkaline conditions, the UPLC method was applied for their determination in the presence of their possible degradation impurities. The separation was performed using C18 column (1.7?m particle size) and isocratic elution system with methanol: 1% o-phosphoric acid (65: 35, v/v). The optimum flow rate was 0.5ml/min and the detection was done at 230nm. The suggested method was validated in compliance with the ICH guidelines and was successfully applied for determination of sodium cromoglicate (SCG) and tetryzoline HCl (TZH) as prepared synthetically in laboratory mixtures, and in the presence of their alkali-induced degradation impurities. The suggested method was effectively applied the determination of spiked rabbit aqueous humor samples as well as commercial pharmaceutical formulation. � 2015 Elsevier B.V.en_US
dc.description.urihttps://www.scimagojr.com/journalsearch.php?q=24172&tip=sid&clean=0
dc.identifier.doihttps://doi.org/10.1016/j.jchromb.2015.10.020
dc.identifier.doiPubMed ID 26547297
dc.identifier.issn15700232
dc.identifier.otherhttps://doi.org/10.1016/j.jchromb.2015.10.020
dc.identifier.otherPubMed ID 26547297
dc.identifier.urihttps://t.ly/DXZX2
dc.language.isoEnglishen_US
dc.publisherElsevieren_US
dc.relation.ispartofseriesJournal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
dc.relation.ispartofseries1006
dc.subjectAqueous humoren_US
dc.subjectDegradationen_US
dc.subjectSodium cromoglicateen_US
dc.subjectTetryzoline HClen_US
dc.subjectUPLCen_US
dc.subjectBiomimeticsen_US
dc.subjectChromatographic analysisen_US
dc.subjectDegradationen_US
dc.subjectImpuritiesen_US
dc.subjectLiquid chromatographyen_US
dc.subjectParticle sizeen_US
dc.subjectSodiumen_US
dc.subjectAqueous humoren_US
dc.subjectChromatographic methodsen_US
dc.subjectPharmaceutical formulationen_US
dc.subjectQuantitative determinationsen_US
dc.subjectSodium cromoglicateen_US
dc.subjectSympathomimetic agentsen_US
dc.subjectTetryzoline HClen_US
dc.subjectUPLCen_US
dc.subjectBody fluidsen_US
dc.subjectcromoglycate disodiumen_US
dc.subjectmethanolen_US
dc.subjectphosphoric aciden_US
dc.subjecttetryzolineen_US
dc.subjectcromoglycate disodiumen_US
dc.subjectimidazole derivativeen_US
dc.subjecttetryzolineen_US
dc.subjectaccuracyen_US
dc.subjectanimal tissueen_US
dc.subjectaqueous humoren_US
dc.subjectArticleen_US
dc.subjectcontrolled studyen_US
dc.subjectdrug degradationen_US
dc.subjectdrug determinationen_US
dc.subjectdrug stabilityen_US
dc.subjectelutionen_US
dc.subjectexperimental rabbiten_US
dc.subjectflow rateen_US
dc.subjectlimit of detectionen_US
dc.subjectlimit of quantitationen_US
dc.subjectnonhumanen_US
dc.subjectpriority journalen_US
dc.subjectseparation techniqueen_US
dc.subjectultra performance liquid chromatographyen_US
dc.subjectvalidation studyen_US
dc.subjectanimalen_US
dc.subjectchemistryen_US
dc.subjectdrug contaminationen_US
dc.subjecthigh performance liquid chromatographyen_US
dc.subjectproceduresen_US
dc.subjectrabbiten_US
dc.subjectreproducibilityen_US
dc.subjectstatistical modelen_US
dc.subjectAnimalsen_US
dc.subjectAqueous Humoren_US
dc.subjectChromatography, High Pressure Liquiden_US
dc.subjectCromolyn Sodiumen_US
dc.subjectDrug Contaminationen_US
dc.subjectImidazolesen_US
dc.subjectLimit of Detectionen_US
dc.subjectLinear Modelsen_US
dc.subjectRabbitsen_US
dc.subjectReproducibility of Resultsen_US
dc.titleDevelopment and validation of impurity-profiling UPLC method for the determination of sodium cromoglicate and tetryzoline hydrochloride: Application on rabbit aqueous humoren_US
dc.typeArticleen_US
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