SIMPLE QUANTIFIED AND VALIDATED STABILITY INDICATING STRESS DEGRADATION STUDIES OF ORAL ANTI-DIABETIC AGENT DAPAGLIFLOZIN BY RP-HPLC METHOD

Objective: This method is focused on developing a precisely simplified and more accurate Reverse Phase–High Pressure Liquid Chromatography (RP-HPLC) for the determination of Dapagliflozin in bulk pharmaceutical dosage form as per guidelines International Council Harmonization (ICH). Methods: Evaluation validation carried out using RP-HPLC ZORBAX (C18) column (250 x 4.6 mm, 5 μm particle size) with mobile phase consisting Phosphate Buffer: Acetonitrile: Methanol ratio 55:40:05 (v/v/v) at flow rate 1 ml/min an injection volume 10 μl. Results: was eluted 2.12±0.05 min detected 225 nm. The regression equation y = 55762 x-29679 found to be linear correlation coefficient r2 value 0.9997. developed conveniently validated ICH robust, sensitive, accurate, selective, specific, precise linear. Conclusion: proposed precise, robust API experimentation analysis. above satisfied Active Pharmaceutical Ingredient (API) formulation study its degradation products.