Method Development and Validation for Determination of Metformin Hydrochloride and Saxagliptin in Bulk and Marketed Preparation

Vaughan Fernandes

Abstract


A simple, accurate and precise spectrophotometric method has been developed for simultaneous determination of Saxagliptin (SAXA) and Metformin hydrochloride (MET) in a laboratory mixture. In absorbance ratio method, isobestic point is observed at 227 nm. Isobestic point (227nm) is considered as λ2 and absorbance maxima of Saxagliptin (210nm) is considered as λ1. Saxagliptin and Metformin hydrochloride were quantified using principle that absorbance difference between two points on mixture spectra is directly proportional to concentration of components of interest and independent of interfering component. All dilutions were prepared in distilled water. Linearity range was observed in the concentration range of solution 5‐50 μg/ml for Saxagliptin and 2-16 μg/ml for Metformin hydrochloride. The methods were validated statistically and recovery study was performed to confirm the accuracy of both drugs.


Keywords


Saxagliptin, Metformin Hydrochloride, Ultraviolet spectroscopy, Absorbance ratio method.

References


Zhou G, Myers R, Li Y, Chen Y, Shen X, Fenky-Melody J, Wu M, Ventre J, Doebber T, Fujii N, Musi N, Hirshman MF, Goodyear LJ and Moller DE. Role of AMP-activated protein kinase in mechanism of metformin action. The Journal of Clinical Investigation. 2001;108(8):1167-1174.

Marc Foretz, Sophie Hébrard, Jocelyne Leclerc, ElhamZarrinpashneh, Maud Soty, Gilles Mithieux, Kei Sakamoto, FabrizioAndreelli and Benoit Viollet, J Clin Invest; 120(7), 2360, (2010).

Onglyza Product information. Bristol-Meyers-Squibb .Princeton New Jersey, USA. 1st July 2009. Available at: http://packageinserts.bms.com/pi/pi_onglyza.pdf (cited 1st August 2010).

Australian Drug Evaluation Committee Recommendations. Australian Government Department of Health and Aging, January 2010. Available at: http://www.tga.gov.au/docs/ html/ adec/adec0267.htm (cited 30th Sept 2010)

Deacon CF, Holst JJ. Saxagliptin: a new dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. Adv Ther 2009; 26(5):488-499

Robertson JG. Discovery and preclinical profile of Saxagliptin (BMS-477118): A highly potent, long-acting, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes . J Med Chem 2005; 48(15): 5025- 37.

Saxagliptin: A clinical review in the treatment of type 2 diabetes mellitus, Clin Ther 2011;33:1005-1022.

Deanna KS., Jasmine GD., Zachary WA., Kulasa K., Edelman S. Saxagliptin: the evidence for its place in the treatment of type 2 diabetes mellitus. Core evidence 2010; 5:23-37

Tahrani AA., Piya MK., Barnett AH. Saxagliptin: a New DPP-4 Inhibitor for the treatment of Type 2 diabetes mellitus. Adv Ther 2011; 26(3): 249-262.

Hess C., Musshoff F., Madea B. Simultaneous identification and validated quantification of 11 oral hypoglycaemic drugs in plasma by electrospray ionisation liquid chromatography–mass spectrometry. Anal Bioanal Chem 2011; 400: 33-41.

Singh S., Sethi S., Khanna V.,Benjamin B.,Kant R., Sattigeri J., Bansal VS, Bhatnagar PK., Davis JA.. A potent, selective and slow-binding inhibitor of dipeptidyl peptidase-IV for the treatment of type 2 diabetes .Eur J Pharmaco 2011; 652: 157-163.

Hess C., Musshoff F., Madea B., 2011, Simultaneous identification and validated quantification of 11 oral hypoglycaemic drugs in plasma by electrospray ionisation liquid chromatography–mass spectrometry, Anal Bioanal Chem, 400, 33-41.

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




URN: https://pmindexing.com/index.php/IJCPA/issue/view/urn:pmi:jr:0011ijcpa.v5i2.14469

DOI: https://pmindexing.com/91.1211/ijcpa.v5i2.1446

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