Development and Validation of a Liquid Chromatographic Method for Estimation of Saxagliptin in Tablet Dosage Form. Karkhanis Vaishali V.1,*, Dr. (Mrs.) Captain Anandkumari D.1 A.R. College of Pharmacy, V.V. Nagar-388120, Gujarat 1G.H. Patel Institute of Pharmacy, V.V. Nagar-388120, Gujarat *Corresponding Author E-mail: vesli@rediffmail.com
Online published on 21 September, 2013. Abstract 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. Top Keywords Saxagliptin (SAX), validation, RP-HPLC, recovery. Top |