Yehia A.M.Sami I.Riad S.M.El-Saharty Y.S.Department of Analytical ChemistryFaculty of PharmacyCairo UniversityKasr El-Aini StreetCairo11562Egypt; Pharmaceutical Analytical Chemistry DepartmentFaculty of PharmacyOctober University for Modern Sciences and Arts6 October City11787Egypt2020-01-092020-01-09201795893https://doi.org/10.1007/s10337-016-3210-1PubMed ID :https://t.ly/AXneGScopusMirabegron is a novel ?3-adrenoceptor agonist containing an amide group. It was subjected to stress conditions of acidic and alkaline hydrolyses. The hydrolytic degradation product was isolated and its structure was confirmed using mass and IR spectrometry. Two stability-indicating chromatographic methods have been proposed for the determination of mirabegron. TLC method was applied using silica gel as stationary phase and chloroform methanol ammonia (9.0:1.0:0.1 by volume) as the mobile phase, and chromatograms were scanned at 250. nm. Accurate determination of the drug was achieved over the concentration range of 2. 1. g per band. In addition, an isocratic HPLC method was developed on Agilent C18 column (150. mm. נ4.5.mm I.D., particle size 5.m) using ethanol-phosphate buffer pH 2.5 (30:70, by volume) as a mobile phase with flow rate of 1.mL.min?1.The intact drug was detected at 255.nm with running time less than 5.min. Mirabegron was determined accurately in a concentration range of 1.25.g.mL?1. The proposed chromatographic methods were applied successfully for the assay of mirabegron in pharmaceutical dosage form and both methods were validated as per the International Conference on Harmonization guidelines and statistically compared with a reported gradient HPLC method. 2016, Springer-Verlag Berlin Heidelberg.EnglishHigh performance liquid chromatographyMirabegronStability indicating methodThin layer chromatographymirabegronsilica gelArticlecomparative studydensitometrydrug degradationdrug determinationdrug formulationdrug releasehigh performance liquid chromatographyhydrolysismeasurement accuracypriority journalthin layer chromatographyArticlehttps://doi.org/10.1007/s10337-016-3210-1PubMed ID :