Abstract

ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION OF DAPAGLIPFLOZIN BY RP-HPLC

Vaishali B. Bhamare* and Dr. Charushila Bhangale

Abstract

A stability indicating RP-HPLC method was developed and validated for analysis of dapaglipflozin in single and dosage form. the separation was achieved by using cosmosil C18 (250mm x 4.6ID, Particle size: 5 μ) as a stationary phase with mobile phase consisting methanol: water (85:15) V/V pH 3. the flow rate 0.9 ml/min and optimum wavelength for detection was 224 nm. the developed method was validated for precision, accuracy, ruggedness, robustness, linearity and range. the developed method showed good linearity range 10-50 μg/ml for dapaglipflozin. the forced degradation studies were performed as per ICH guidelines under acidic, alkali, photolytic, thermolytic conditions. the developed RP-HPLC method was found to be linear over wider concentration range. thus the developed RP-HPLC method can be use for routine quantitative and qualitative analysis of dapaglipflozin in bulk and pharmaceutical formulations like tablets and validated as per ICH guidelines. Hence proposed method could be employed for stability studies on pharmaceutical preparations within pharmaceutical industry.

Keywords: Dapagliflozin, HPLC, Methanol, Reverse Phase Chromatography, Validation.