Fathy M. Salama, Khalid A. M. Attia, Ahmed A. Abouserie, Ragab A. Mabrouk, and Ahmed M Abdelzaher
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, 11751 Nasr City, CAIRO, EGYPT
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A novel stability-indicative of TLC densitometric method has been developed for estimation of ipragliflozin in bulk drugs and pharmaceutical dosage form in the presence of its oxidative degradation products. The proposed method based on determination of the UV-visualized bands after TLC separation of drug. The studied drugs were quantitatively separated on 60 F254 silica gel plates using mobile phase consists of [ Methanol : n-hexane : Ethyl acetate : Acetonitrile (1 : 1 : 1 : 0.1, by volume) ] with UV detection at 230 nm. The studied drugs were satisfactorily resolved with retention factor (Rf) values of 0.77 ± 0.005 and 0.29 ± 0.01 for ipragliflozin and its oxidative degradation products, respectively. The proposed method has been validated according to ICH guidelines and show high sensitivity, accuracy and precision and the results were statistically compared to manufacturing method.