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Application of Accelerated Stability Studies on Linagliptin by HPTLC
Asian Journal of Chemistry,
Vol. 29 No. 1 (2017): Vol 29 Issue 1
Abstract
Linagliptin is an inhibitor of dipeptidylpeptidase-4 (DPP-4) enzyme that degrades the incretin hormones glucagon-like peptide-1 and glucose-dependent insulin tropic polypeptide and is used to lower the increased blood sugar level. High performance thin layer chromatography method was used for chromatographic separation of linagliptin. As stability testing is major step in the development of new drug as well as formulation, stress degradation studies were carried out according to ICH guidelines. Linagliptin was found susceptible to all the analyzed stress conditions. Chromatographic resolution of linagliptin and its degradation products was achieved by using precoated silica gel 60 F254 aluminium plates as stationary phase and chloroform:methanol (8.5:1.5, v/v) as optimum mobile phase. Densitometric detection was carried out at 242 nm. The developed method has been successfully applied for the estimation of linagliptin in tablet dosage form.
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- International Conference on Harmonization (ICH), Q1A (R2): Stability testing of new drug substances and products, IFPMA, Geneva (2003).
- World Health Organization (WHO), Draft Stability Testing of Active Pharmaceutical Ingredients and Pharmaceutical Products, Geneva (2007).
- https://en.wikipedia.org/wiki/Linagliptin (accessed on 03/05/2015).
- C.K. Sekhar, P. Sudhakar, T. Mohan Rao, P. Vijaya Babu and K.A. Manikanta, Int. J. Univ. Pharm. Bio. Sci., 2, 1 (2013).
- S. Banik, P. Karmakar and A.H. Miah, Bangladesh Pharm. J., 18, 163 (2015).
- N. Padmaja and G. Veerabhadram, Der Pharm. Lett., 7, 306 (2015).
- R. El-Bagary, E.F. Elkady and B.M. Ayoub, Int. J. Biomed. Sci., 9, 41 (2013).
- S.S. Mahamad Shafi, A. Begum and N.D.V.R. Saradhi, Int. J. Bioassays, 3, 3146 (2014).
- R.H. Pandya, R. Rathod and D.G. Maheswari, Pharmacophore, 5, 202 (2014).
- N. Dubey, G.N. Singh, A. Tyagi, R. Bhardwaj and C.S. Raghav, Indian J. Chem., 53B, 1136 (2014).
- R.B. Lakshman, Am. J. PharmTech. Res., 2, 463 (2012).
- K. Sujatha and J.V.L.N. Seshagiri Rao, Indo Am. J. Pharm. Res., 3, 8376 (2013).
- T.V. Reddy, J. Atoms Molecules, 2, 155 (2012).
- M. Archana, N. Sriram and M.D. Gayasuddin, Int. J. Med. Chem. Anal., 3, 1 (2013).
- A. Janardhan Swamy and K.H. Baba, Int. J. Pharm., 3, 594 (2013).
- S. Moncy, G. Rohini Reddy, P.S. Chaitanya, G. Priyanka and E. Hima Bindu, Indo Am. J. Pharm. Res., 4, 4047 (2014).
- S. Shirisha, M.M. Akiful Haque, D. Sireesha, V. Bakshi and S. Harshini, Int. J. Pharm. Res. Health Sci., 2, 491 (2014).
- C. Varaprasad, M. Asif and K. Ramakrishna, Rasayan J. Chem., 8, 426 (2015).
- C. Veeresham, P. Vemula, D. Dodda, U. Balekari and S. Panga, J. Adv. Pharm. Technol. Res., 6, 25 (2015).
- B.R.C. Sekhar Reddy, N.V. Bhaskar Rao and K. Saraswathi, Der Pharm. Sinica, 5, 131 (2014).
- K.Y. Kavitha, G. Geetha, R. Hariprasad, R. Venkatnarayanan and M. Kaviarasu, J. Chem. Pharm. Res., 5, 230 (2013).
- A.R. Varma, J.V. Shanmukhakumar and S.M. Reddy, Int. J. Innov. Tech. Res., 2, 1131 (2014).
- N.M. Rao and D.G. Sankar, Int. J. Pharm. Pharm. Sci., 7, 191 (2015).
- A. Rajasekaran, R. Kavitha and R. Arivukkarasu, World J. Pharm. Sci., 2, 317 (2014).
- International Conference on Harmonization (ICH), Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva (2005).
References
International Conference on Harmonization (ICH), Q1A (R2): Stability testing of new drug substances and products, IFPMA, Geneva (2003).
World Health Organization (WHO), Draft Stability Testing of Active Pharmaceutical Ingredients and Pharmaceutical Products, Geneva (2007).
https://en.wikipedia.org/wiki/Linagliptin (accessed on 03/05/2015).
C.K. Sekhar, P. Sudhakar, T. Mohan Rao, P. Vijaya Babu and K.A. Manikanta, Int. J. Univ. Pharm. Bio. Sci., 2, 1 (2013).
S. Banik, P. Karmakar and A.H. Miah, Bangladesh Pharm. J., 18, 163 (2015).
N. Padmaja and G. Veerabhadram, Der Pharm. Lett., 7, 306 (2015).
R. El-Bagary, E.F. Elkady and B.M. Ayoub, Int. J. Biomed. Sci., 9, 41 (2013).
S.S. Mahamad Shafi, A. Begum and N.D.V.R. Saradhi, Int. J. Bioassays, 3, 3146 (2014).
R.H. Pandya, R. Rathod and D.G. Maheswari, Pharmacophore, 5, 202 (2014).
N. Dubey, G.N. Singh, A. Tyagi, R. Bhardwaj and C.S. Raghav, Indian J. Chem., 53B, 1136 (2014).
R.B. Lakshman, Am. J. PharmTech. Res., 2, 463 (2012).
K. Sujatha and J.V.L.N. Seshagiri Rao, Indo Am. J. Pharm. Res., 3, 8376 (2013).
T.V. Reddy, J. Atoms Molecules, 2, 155 (2012).
M. Archana, N. Sriram and M.D. Gayasuddin, Int. J. Med. Chem. Anal., 3, 1 (2013).
A. Janardhan Swamy and K.H. Baba, Int. J. Pharm., 3, 594 (2013).
S. Moncy, G. Rohini Reddy, P.S. Chaitanya, G. Priyanka and E. Hima Bindu, Indo Am. J. Pharm. Res., 4, 4047 (2014).
S. Shirisha, M.M. Akiful Haque, D. Sireesha, V. Bakshi and S. Harshini, Int. J. Pharm. Res. Health Sci., 2, 491 (2014).
C. Varaprasad, M. Asif and K. Ramakrishna, Rasayan J. Chem., 8, 426 (2015).
C. Veeresham, P. Vemula, D. Dodda, U. Balekari and S. Panga, J. Adv. Pharm. Technol. Res., 6, 25 (2015).
B.R.C. Sekhar Reddy, N.V. Bhaskar Rao and K. Saraswathi, Der Pharm. Sinica, 5, 131 (2014).
K.Y. Kavitha, G. Geetha, R. Hariprasad, R. Venkatnarayanan and M. Kaviarasu, J. Chem. Pharm. Res., 5, 230 (2013).
A.R. Varma, J.V. Shanmukhakumar and S.M. Reddy, Int. J. Innov. Tech. Res., 2, 1131 (2014).
N.M. Rao and D.G. Sankar, Int. J. Pharm. Pharm. Sci., 7, 191 (2015).
A. Rajasekaran, R. Kavitha and R. Arivukkarasu, World J. Pharm. Sci., 2, 317 (2014).
International Conference on Harmonization (ICH), Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva (2005).