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.

  • David W Boulton, Angela Tang, Chirag Patel, Lorna Castaneda, Uli Frevert, Li Li, David M Kornhauser. A Comparision of the single-dose pharmacokinetics and safety of Saxagliptin insubjects with hepatic impairment and in healthy subjects. European Journal of InternalMedicine 20S (2009), S1–S283.

  • Fura, Khanna, Vyas, Koplowitz, Shu-Ying Chang, Caporuscio, et al, Pharmacokinetics of the Dipeptidyl Peptidase 4 inhibitor Saxagliptin in Rats, Dogs, and Monkeys and Clinical Projections. Drug Metab Dispos. 2009; 37: 1164-1171.

  • Chirag G Patel, Li Li, Suzette Girgis, David M Kornhauser, Ernest U Frevert, David W Boulton.., Twoway pharmaco kinetic interaction studies between saxagliptin and cytochrome P450 substrates or inhibitors: simvastatin, diltiazem extended-release, and ketoconazole. Clinical Pharmacology: Advances and Applications 2011:2,13–25.

  • Cornelius Hess, Frank Musshoff and Burkhard Madea.., Simultaneous identification and validated quantification of 11 oral hypoglycaemic drugs in plasma by electrospray ionisation liquid chromatography–mass spectrometry, Analytical and Bioanalytical Chemistry 2011, 400: 33-41.

  • Kalaichelvi R, Jayachandran E, Validated Spectroscopic method for the estimation of Saxagliptin in pure and from tablet formulation. Int J Pharm Pharm Sci. 2011; 3: 179-180

  • 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: 418  |  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