VALIDATED AND QUANTIFIED STABILITY INDICATING STRESS DEGRADATION STUDY OF ORAL ANTI-DIABETIC AGENT CANAGLIFLOZIN BY RP-HPLC METHOD

Objective: The present investigation is aimed to develop and validate, a simple, consistent sensitive stability-indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for the determination of oral anti-diabetic drug Canagliflozin in bulk pharmaceutical dosage form as per International Council Harmonization Technical Requirements Pharmaceuticals Human Use (ICH-Q2 (R1)). Methods: chromatographic separation was achieved by using Reverse Phase-High Performance Liquid Chromatography ZORBAX C18 (250 mm x 4.6 mm, 5μm particle size) with mobile phase consisting Acetonitrile: Water ratio 53:47% v/v at flow rate 1 ml/min an injection volume 20 μl. Results: Retention time found be 2.36±0.05 min detected 214 nm UV wavelength. linear regression equation y = 60702x–2156.2 correlation coefficient 0.9999. Stress degradation studies were performed exposing into acidic, alkaline, oxidative, thermal photolytic stress conditions active samples withdrawn different intervals ICH guidelines. Conclusion: proposed Phase High-Performance robust, precise specific estimation forms.