Development and Validation of a Liquid Chromatographic Method for Estimation of Saxagliptin in Tablet Dosage Form.

An accurate, sensitive and precise RP-HPLC method has been developed and validated for the estimation of Saxagliptin (SAX) from bulk drug and Pharmaceutical Dosage form. The separation was achieved by Hypersil C18 column (250mm X 4.6mm, 5μm) in isocratic mode, with mobile phase comprises of Acetonitrile: Buffer in proportion of 30:70v/v, buffer was 0.02M Potassium Di-hydrogen Phosphate (pH 4.5 adjusted with Ortho Phosphoric Acid). The flow rate of mobile phase was 1.0ml/min and employing UV detection with 220nm wavelengths. The retention time of SAX was 3.487 min.The calibration curve was found to be linear within the concentration range of 50μg/ml to 150μg/ml. The regression data for calibration curve shows good linear relationship with r² = 0.9999. The method was validated in accordance with the requirements of ICH guidelines. Moreover, the proposed analytical method was applied to monitor the formulation commercially available.