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Stability Indicating HPLC method Development and Validation for Simultaneous estimation of Metformin, Dapagliflozin and Saxagliptin in Bulkdrug and Pharmaceutical Dosage Form.

A simple, precise and rapid stability-indicating RP-HPLC was developed and validated for the estimation of Metformin, Dapagliflozin and Saxagliptin combination in bulk and tablet dosage form. The proposed method uses a Kromasil C18 column (150 x 4.6) mm, 5μm with column oven temperature of 30°C and mobile phase containing a mixture of 60% phosphate buffer (pH=3) and 40% acetonitrile. The flow rate was set at 1.0 ml/min and the injection volume is 10 μl. The detection was carried out at 230 nm using a photodiode array detector, and the total run time was 4 minutes. The proposed method was validated according to ICH guidelines with respect to specificity, linearity, precision, accuracy, robustness and solution stability. The method is linear over the range of 125-750 μg/mL for Metformin (MET), 1.25-7.5 μg/mL for Dapagliflozin (DAP) and 0.625-3.75 μg/mL and for Saxagliptin (SAX). The observed correlation coefficients (R2 ) for MET, DAP and SAX are > 0.999. The proposed method is precise and the percentage relative standard deviation found to be between 0.4 and 0.8. The observed percentage recoveries are in between 98.51 to 100.80 for all three compounds. The product was subjected to the stress conditions of acid, base, oxidative, thermal and photolytic degradation. The product was found to degrade significantly in oxidative, acid and base hydrolysis degradation conditions and the degradation products were well resolved from the active peaks, thus proving the stability-indicating power of the method. The developed and validated stability-indicating RP-HPLC method was appropriate for quantitative determination of these drugs in pharmaceutical preparations and also quality control in bulk manufacturing.