DEVELOPMENT AND VALIDATION OF STABILITY INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND SAXAGLIPTIN IN COMBINED DOSAGE FORM

Abstract

An isocratic, reversed phase-liquid-chromatographic method was developed for the quantitative determination of Metformin and Saxagliptin in combined-dosage form. A thermo hypersil BDS C8 (250*4.6*5µ) column with mobile phase containing water pH 3.0 adjusted with ortho phosphoric acid: methanol in the ratio of (70: 30, v/v) was used. The flow rate was 1.0 mL/min, column temperature was 30°C and effluents were monitored at 241 nm. The retention times of Metformin and Saxagliptin were 2.956min and 4.573 min, respectively. The correlation co-efficient for Metformin and Saxagliptin was found to be 1 and 0.999, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of Metformin and Saxagliptin in formulations was found to be in the range of 100% and 99-100% respectively confirms the non-interferences of the excipients in the formulation. Due to its simplicity, rapidness and high precision. The method was successfully applied to the estimation of Metformin and Saxagliptin in combined dosage form.