Browsing by Author "El-Saharty Y.S."

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Comparison of Two Stability-Indicating Chromatographic Methods for the Determination of Mirabegron in Presence of Its Degradation Product
(Friedr. Vieweg und Sohn Verlags GmbH, 2017) Yehia A.M.; Sami I.; Riad S.M.; El-Saharty Y.S.; Department of Analytical Chemistry; Faculty of Pharmacy; Cairo University; Kasr El-Aini Street; Cairo; 11562; Egypt; Pharmaceutical Analytical Chemistry Department; Faculty of Pharmacy; October University for Modern Sciences and Arts; 6 October City; 11787; Egypt
Mirabegron 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.
Qualitative and quantitative chemometry as stability-indicating methods for determination of dantrolene sodium and paracetamol
(Bentham Science Publishers B.V., 2018) Yehia A.M.; Sami I.; Riad S.M.; El-Saharty Y.S.; Cairo University; Faculty of Pharmacy; Department of Analytical Chemistry; Kasr El-Aini Street; Cairo; ET 11562; Egypt; October University for Modern Sciences and Arts; Faculty of Pharmacy; Pharmaceutical Analytical Chemistry Department; 6 October City; 11787; Egypt
Background: Simultaneous determination of binary mixtures with simple and cost effective analysis is always of interest. Progressive advancement in chemometrics enables spectral resolution of drugs in the presence of their degradation products or impurities. Methods and Result: Three stability indicating chemometric methods are applied for the simultaneous determination of Dantrolene sodium (DNT) and Paracetamol (PAR). Partial Least Squares (PLS), Concentration Residuals Augmented Classical Least Squares (CRACLS) and Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) were selected for that purpose. DNT and PAR were determined in the linearity range of (2 � 10 ?g mL-1) and (12 � 28 ?g mL-1), respectively, in the presence of their degradation products. The presented methods were compared for their qualitative and quantitative analyses and validated according to the ICH guidelines. Furthermore, statistical comparison between the results obtained by the proposed methods and the reported chromatographic method showed no significant differences. Conclusion: The proposed multivariate calibrations were accurate and specific for quantitative analysis of the studied components. Furthermore, CRACLS and MCR-ALS methods succeeded in both quantitative and qualitative of the studied components and their degradation products. � 2018 Bentham Science Publishers.