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Captain, Anandkumari D.
- Development and Validation of a Liquid Chromatographic Method for Estimation of Saxagliptin in Tablet Dosage form
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Authors
Affiliations
1 A.R. College of Pharmacy and G.H. Patel Institute of Pharmacy V.V. Nagar-388120 Gujarat
1 A.R. College of Pharmacy and G.H. Patel Institute of Pharmacy V.V. Nagar-388120 Gujarat
Source
Asian Journal of Research in Chemistry, Vol 6, No 6 (2013), Pagination: 552-554Abstract
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.Keywords
Saxagliptin (SAX) ,Validation, RP-HPLC, Recovery
References
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