ISSN: 2249–9504
CAS CODEN: IJPCDX

METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS DETERMINATION OF METFORMIN AND SAXAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM

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.

Get the App