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Study of Degradation Behaviour of Alogliptin Benzoate by Stability Indicating High Performance Thin Layer Chromatographic Method
Corresponding Author(s) : Jasmina Shivlal Surati
Asian Journal of Chemistry,
Vol. 29 No. 7 (2017): Vol 29 Issue 7
Abstract
A simple, selective, precise, rapid and accurate stability indicating HPTLC method was developed and validated for estimation of alogliptin benzoate in tablet dosage form. In this work, alogliptin was estimated using n-butanol:water:acetic acid (7:2:1 v/v/v) as mobile phase and aluminium backed TLC plates pre-coated with 250 μm layer of silica gel 60F254 as stationary phase. The detection carried out at 233 nm. The linearity range was found to be 200–600 ng/spot (r2 = 0.9941). Validation of developed method was performed as per ICH guidelines. Stress testing of alogliptin was performed under acidic, alkaline, oxidative, photolytic and dry heat degradation conditions. The chromatographic conditions successfully resolved alogliptin from its degradation products, formed under various stress conditions. Alogliptin was not significantly degraded in oxidative, photolytic and dry heat degradation conditions and is prone to acidic and alkaline hydrolysis. Tablet dosage form of alogliptin was analyzed by the developed method.
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- R. Christopher and A. Karim, Clin. Pharmacol., 2, 589 (2009); https://doi.org/10.1586/ecp.09.45.
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References
R. Christopher and A. Karim, Clin. Pharmacol., 2, 589 (2009); https://doi.org/10.1586/ecp.09.45.
R.I. El-Bagary, E.F. Elkady and B.M. Ayoub, Int. J. Biomed. Sci., 8, 215 (2012).
K. Zhang, P. Ma, W. Jing and X. Zhang, Asian J. Pharm. Sci., 10, 152 (2015); https://doi.org/10.1016/j.ajps.2015.01.001.
Y. Zhou, W. Zhou, L. Sun, Q.G. Zou, P. Wei and P.K. OuYang, J. Sep. Sci., 37, 1248 (2014); https://doi.org/10.1002/jssc.201301384.
P.J. Yadav, V.N. Kadam and S.K. Mohite, J. Curr. Pharm. Res., 4, 1286 (2014).
G.S. Sri, S.A. Kumar, J. Saravanan, M. Debnath, V. Greeshma and N.S. Krishna, Indo Am. J. Pharm. Res., 3, 9222 (2013).
A.P. Kumar, G. Aruna, K. Rajasekar and P.J. Reddy, Int. Bull. Drug Res., 3, 58 (2013).
K. Swathi, Int. J. Pharm. Res. Health Sci., 3, 747 (2015).
M. Anusha, A. Manzoor, S.A. Satishkumar and K.C.A. Vijaya, Int. J. Uni. Pharm. Bio. Sci., 3, 363 (2014).
K. Raval and U. Srinivasa, Pharm., 5, 56 (2015).
K. Raval and U. Srinivasa, Int. J. Curr. Res., 6, 10201 (2014).
K. Raval and U. Srinivasa, Int. J. Pharm. Pharm. Sci., 6, 730 (2014).
D.B. Sen, A.K. Sen, A. Zanwar, R. Balaraman and A.K. Seth, Int. J. Pharm. Pharm. Sci., 7, 380 (2015).
S.C. Daswadkar, M.A. Roy, S.G. Walode and C.B. Mahendra Kumar, Int. J. Chem. Sci., 14, 649 (2016).
C. Parle and A. Parle, Pharmachem., 6, 303 (2014).
K. Sharma, A. Parle and S. Ahmad, Der Pharm. Lett., 7, 321 (2015).
K.S. Ashutosh, D. Manidipa, R.J.V.L.N. Seshagiri and S.D. Gowri, J. Chromatogr. Sep. Tech., 6, 293 (2015); https://doi.org/10.4172/2157-7064.1000293.
S. Singh and M. Bakshi, Pharm. Tech., 24, 1 (2000).
Stability Testing of New Drug Substances and Products, In: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, Q1A (R2) (2003).
Validation of Analytical Procedures: Text and Methodology, In: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, Q2 (R1) (2005).