IJBPAS, October, 2017, 6(10): 2007-2021 ISSN: 2277–4998 2007 IJBPAS, October, 2017, 6(10) CHROMATOGRAPHIC SIMULTANEOUS QUANTIFICATION OF DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE IN PRESENCE OF THEIR DEGRADATION PRODUCTS SHERIF A. ABDEL-GAWAD 1, 2* , ABDUL MALIK S. AL-TAMIMI 1 , ELSADIG H.K. ADAM 1 1 Pharmaceutical Chemistry Department, College of Pharmacy, Prince Sattam Bin-Abdul Aziz University, Al-Kharj, 11942, Kingdom of Saudi Arabia 2 Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, ET-11562, Egypt *Corresponding author: sagawad@yahoo.com : Tel.: +966 540586921 Fax: +966115886001 ABSTRACT A reversed phase high-performance liquid chromatographic (RP-HPLC) method was adopted and validated as a stability indicating method for the simultaneous quantification of dapagliflozin (DAPA) and metformin (MET) hydrochloride in presence of their degradation products. The degradation process was carried out under acidic, basic, oxidative and thermal conditions, as recommended by the International Conference on Harmonization (ICH)-guidelines. Also, the stability of either the bulk or tablet forms was studied under the storage conditions indicated by the ICH-guidelines (temperature of 40 o C and relative humidity of 75%, for 6 months). Validation parameters such as linearity, accuracy, precision, specificity, limits of detection and quantification (LOD& LOQ) were determined. The best chromatographic separation pattern was acquired on using Hypersil TM ODS C 18 column (150 x 4.6 mm, 5 µm) as a stationary phase and 0.05 M potassium dihydrogen phosphate buffer (adjusted to pH 4.6 using orthophosphoric acid):acetonitrile:methanol (5:4:1, by volumes), as a mobile phase. It was pumped using an isocratic mode with flow rate of 0.5mL/min. and UV detection at 236 nm. The calibration graph was linear in the range of 0.5 -20 µg/mL, for DAPA and 50 – 550 µg/mL, for MET. The