Development and validation of spectrophotometric method for the determination of DPP-4 inhibitor, sitagliptin, in its pharmaceutical preparations

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Published: Sep 30, 2010
DOI: https://doi.org/10.26850/1678-4618eqj.v35.3.2010.p45-53
Keywords:
sitagliptin phosphate, acetyl acetone; Beer's law, Sandell's sensitivity

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Chandra Bala Sekaran
J. K. C. College, Department of Biotechnology, Guntur, India.
Avula Prameela Rani
K.V.S.R. Siddhartha College of Pharmaceutical Sciences, Department of Pharmaceutics, Vijayawada, India.

Abstract

A simple, sensitive and reproducible spectrophotometric method was developed for the determination of sitagliptin phosphate in bulk and in pharmaceutical formulations. The proposed method is based on condensation of the primary amino group of sitagliptin phosphate with acetyl acetone and formaldehyde producing a yellow colored product, which is measured spectrophotometrically at 430nm. The color was stable for about 1 hour. Beer’s law is obeyed over a concentration range of 5-25 μg/ml. The apparent molar absorptivity and Sandell sensitivity values are 1.067 x 104 Lmol-1cm-1 and 0.0471 μgcm-2 respectively. All the variables were studied to optimize the reaction conditions. No interference was observed in the presence of common pharmaceutical excipients. The validity of the method was tested by analyzing sitagliptin phosphate in its pharmaceutical preparations. Good recoveries were obtained. The developed method was successfully employed for the determination of sitagliptin phosphate in various pharmaceutical preparations.

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How to Cite
Sekaran, C. B., & Rani, A. P. (2010). Development and validation of spectrophotometric method for the determination of DPP-4 inhibitor, sitagliptin, in its pharmaceutical preparations. Eclética Química, 35(3), 45–53. https://doi.org/10.26850/1678-4618eqj.v35.3.2010.p45-53
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Vol. 35 No. 3 (2010): Eclética Química
Section
Original articles
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References

G. Herman, C. Stevens, K. Van Dyck, A. Bergman, Yi B, M. De Smet, K. Snyder, D. Hilliard, M. Tanen, W. Tanaka, A. Wang, W. Zeng, D. Musson, G. Winchell, M. Davies, S. Ramael, K. Gottesdiener and J. Wagner,

Clinical Pharmacology and Therapeutics. 78(6) (2005) 675.

Januvia Side Effects & Drug Interactions. RxList. com, 2007.

U.S. Food and Drug Administration. FDA Approves New Treatment for Diabetes. 2006.

G. Herman, A. Bergman, F. Liu, C. Stevens, A. Wang, W. Zeng, L. Chen, K. Snyder, D. Hilliard, M. Tanen, W. Tanaka, A. Meehan, K. Lasseter, S. Dilzer, R. Blum and J. Wagner. Journal of Clinical Pharmacology.

(8) (2006) 876.

H. Stella Vincent, R. James Reed, A. J. Bergman, C. S. Elmore, Bing Zhu, Shiyao Xu, David Ebel, Patrick Larson, Wei Zeng, Li Chen, Stacy Dilzer, Kenneth Lasseter, Keith Gottesdiener, J. A. Wagner and G. A.

Herman. Drug Metabolism and Disposition. 35(4) (2007) 533.

Wei Zeng, Donald G Musson, Alison L Fisher, Li Chen, Michael S Schwartz, Eric J Woolf and Amy Qiu Wang. Journal of Pharmaceutical and Biomedical Analysis. 2008; 46(3) (2008) 534.

Ramakrishna Nirogi, Vishwottam Kandikere, Koteshwara Mudigonda, Prashanth Komarneni, Raghupathi Aleti, Rajeshkumar Boggavarapu. Biomedical Chromatography. 22(2) (2008) 214.

M. G. Beconi, J. R. Reed, Yohannes Teffera, Yuan-Qing Xia, C. J. Kochansky, D. Q. Liu, Shiyao Xu, C. S. Elmore, Suzanne Ciccotto, D. F. Hora, R. A. Stearns, and S. H. Vincent. Drug Metabolism and Disposition.

(4) (2007) 525.

F. R. S Derker Bratlon and W. David Olis. Comprehensive Organic Chemistry, The Synthesis and Reactions of Organic Compounds. 4, Pergamon Press, London, 65, 1979, pp. 298.

A. S. Amin and M. M. Zareh. Microchimica Acta., 124(3-4) (1996) 227.

A. S. Ahmad, M. D. Hoda N, M. Ahmad, F. Islam and S. Z. Qureshi. Journal of Analytical Chemistry. 61(9) (2006) 870.

A. Fawzy. El-Yazbi, H. H. Abdine and R. A. Shaalan.

Journal of Pharmaceutical and Biomedical Analysis. 19(6) (1996) 819.

M. M. Ayad, M. M. El-Henawee, H. E. Abdellatef, H. M. El-Sayed. Alexandria Journal of Pharmaceutical Sciences. 9(2) (2005) 157.

Khalifa Abulghasem El-Aroud, Adel Mohamed Abushoffa and Hisham Ezzat Abdellatef. Chem. Pharm. Bull. 55(3) (2007) 364.

Analytical Methods Committee, 1987. Recommendations for the definition, estimation and use of the detection limit. 1987. Analyst., pp:199

H. F. Askal, G. A. Saleh, N. M. Omar, Analyst, 116(4) (1991) 387.