Lotfy H.M.Saleh S.S.Hassan N.Y.Salem H.Analytical Chemistry DepartmentFaculty of PharmacyCairo UniversityKasr-El AiniCairo11562Egypt; Pharmaceutical Chemistry departmentFaculty of Pharmaceutical sciences and Pharmaceutical industriesFuture University in Egypt (FUE)Cairo12311Egypt; Analytical Chemistry DepartmentFaculty of PharmacyOctober University for Modern Sciences and Arts (MSA)6th October11787Egypt; Analytical Chemistry DepartmentFaculty of PharmacyDeraya UniversityMiniaEgypt2020-01-092020-01-09201515700232https://doi.org/10.1016/j.jchromb.2015.10.020PubMed ID 26547297https://t.ly/DXZX2ScopusMSA Google ScholarSodium 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.EnglishAqueous humorDegradationSodium cromoglicateTetryzoline HClUPLCBiomimeticsChromatographic analysisDegradationImpuritiesLiquid chromatographyParticle sizeSodiumAqueous humorChromatographic methodsPharmaceutical formulationQuantitative determinationsSodium cromoglicateSympathomimetic agentsTetryzoline HClUPLCBody fluidscromoglycate disodiummethanolphosphoric acidtetryzolinecromoglycate disodiumimidazole derivativetetryzolineaccuracyanimal tissueaqueous humorArticlecontrolled studydrug degradationdrug determinationdrug stabilityelutionexperimental rabbitflow ratelimit of detectionlimit of quantitationnonhumanpriority journalseparation techniqueultra performance liquid chromatographyvalidation studyanimalchemistrydrug contaminationhigh performance liquid chromatographyproceduresrabbitreproducibilitystatistical modelAnimalsAqueous HumorChromatography, High Pressure LiquidCromolyn SodiumDrug ContaminationImidazolesLimit of DetectionLinear ModelsRabbitsReproducibility of ResultsArticlehttps://doi.org/10.1016/j.jchromb.2015.10.020PubMed ID 26547297