Asian Journal of Research in Chemistry

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


Affiliations
1 A.R. College of Pharmacy and G.H. Patel Institute of Pharmacy V.V. Nagar-388120 Gujarat
     

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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
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  • . http://www.drugbank.ca/drugs/DB06335.

  • Deanna S. Kania, Jasmine D. Gonzalvo, and Zachary A.Weber.., Saxagliptin: A Clinical Review in the Treatment of Type 2 Diabetes Mellitus.Clinical Therapeutics 2011,Vol.33, 1005-1022.

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  • Srikanth Inturi,Ravikanth Inturi, Israelkumar Tagaram Validated novel LC determination of Saxagliptin in pure and Pharmaceutical dosage forms. International Journal of Pharmaceutical Research aand Development. 2011; 3(8): 45-52.

  • International Conference of Harmonisation (ICH) of Technical Requirement for the registration of Pharmaceuticals for human use. Validation of Analytical Procedures Methodology, ICH-Q 213, Geneva (1996)


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  • Development and Validation of a Liquid Chromatographic Method for Estimation of Saxagliptin in Tablet Dosage form

Abstract Views: 350  |  PDF Views: 3

Authors

Vaishali V. Karkhanis
A.R. College of Pharmacy and G.H. Patel Institute of Pharmacy V.V. Nagar-388120 Gujarat
Anandkumari D. Captain
A.R. College of Pharmacy and G.H. Patel Institute of Pharmacy V.V. Nagar-388120 Gujarat

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.

Keywords


Saxagliptin (SAX) ,Validation, RP-HPLC, Recovery

References