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.
Cite this article:
Vaishali V. Karkhanis, (Mrs.) Anandkumari D. Captain. Development and Validation of a Liquid Chromatographic Method for Estimation of Saxagliptin in Tablet Dosage Form. Asian J. Research Chem. 6(6): June 2013; Page 552-554.
Cite(Electronic):
Vaishali V. Karkhanis, (Mrs.) Anandkumari D. Captain. Development and Validation of a Liquid Chromatographic Method for Estimation of Saxagliptin in Tablet Dosage Form. Asian J. Research Chem. 6(6): June 2013; Page 552-554. Available on: https://ajrconline.org/AbstractView.aspx?PID=2013-6-6-8