Fawaz E.M.El-Rahman M.K.A.Riad S.M.Shehata M.A.Analytical Chemistry DepartmentFaculty of PharmacyCairo UniversityKasr-El Aini StreetCairo11562Egypt; Analytical Chemistry DepartmentFaculty of PharmacyOctober for Modern Sciences and Arts University6th of October CityEgypt2020-01-092020-01-0920172693879https://doi.org/10.1002/bmc.3799PubMed ID 27460216https://t.ly/j6vG0ScopusThe X-ray diagnostic agent sodium diatrizoate (DTA) was studied for chemical degradation. The 3,5-diamino derivative was found to be the alkaline and acidic degradation product. The 3,5-diamino degradate is also the synthetic precursor of DTA and it is proved to have cytotoxic and mutagenic effects. A sensitive, selective and precise high-performance liquid chromatographic stability-indicating method for the determination of DTA in the presence of its acidic degradation product and in pharmaceutical formulation was developed and validated. Owing to the high toxicity of the degradation product, the kinetics of the acidic degradation process was monitored by the developed RP-HPLC method. The reaction was found to follow pseudo-first order kinetics. The kinetic parameters such as rate constant (K) and half-life (t�) were calculated under different temperatures and acid concentrations; activation energy was estimated from the Arrhenius plot. The developed RP-HPLC method depends on isocratic elution of a mobile phase composed of methanol�water (25:75 v/v; pH adjusted with phosphoric acid), and UV detection at 238 nm. The method showed good linearity over a concentration range of 2�100 ?g/mL with mean percentage recovery of 100.04 � 1.07. The selectivity of the proposed method was tested using laboratory-prepared mixtures. The proposed method has been successfully applied to the analysis of DTA in pharmaceutical dosage forms without interference from other dosage form additives and the results were statistically compared with the official USP method. Validation of the proposed method was performed according to International Conference on Harmonization guidelines. Copyright � 2016 John Wiley & Sons, Ltd.EnglishOctober University for Modern Sciences and Artsجامعة أكتوبر للعلوم الحديثة والآدابUniversity of Modern Sciences and ArtsMSA Universitydiatrizoate sodiumkinetic studyRP-HPLCstabilitydiatrizoatemeglumine diatrizoate plus sodium diatrizoatemethanolphosphoric acidwatercontrast mediumdiatrizoateArticlecytotoxicitydegradation kineticsdrug formulationdrug half lifedrug monitoringdrug solutiondrug stabilityhigh performance liquid chromatographymutagenic activitypHpowderquality controlradiation detectionrate constanttemperatureultraviolet radiationultraviolet spectroscopydrug stabilityevaluation studyhigh performance liquid chromatographyhumankineticsmetabolismproceduresreproducibilityChromatography, High Pressure LiquidContrast MediaDiatrizoateDrug StabilityHumansKineticsReproducibility of ResultsArticlehttps://doi.org/10.1002/bmc.3799PubMed ID 27460216