Abstract
Author(s): ACK. Prasanna*, Kanuri Priyanka
Aim: An RP-HPLC method has been developed for the simultaneous determination of metformin and saxagliptin in marketed formulation.
Methods: This method is based on RP-HPLC separation of the two drugs on the Inspire C18 column (250 mm × 4.6 mm, 5.0μ); and mobile phase containing Buffer: Methanol in a ratio of 55:45 v/v at a flow rate of 1 ml/min, using UV detection at 208 nm. This method has been applied to formulation without any interference of excipients of formulation.
Results: The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration ranges of 60–100 μg/ml for metformin and 0.6–1.0 μg/ml for saxagliptin respectively. The method was validated as per the ICH guidelines. The limit of detection (LOD) and limit of quantitation (LOQ) was 0.17 μg/ml and 0.064 μg/ml for metformin and 0.08 μg/ml and 0.02 μg/ml for saxagliptin, respectively. Result of assay and recovery study was statistically evaluated for its accuracy and precision.
Conclusion: According to the validation results, the proposed method was found to be specific, accurate, precise and economic for the determination of metformin and saxagliptin in pharmaceutical dosage forms.