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RP-HPLC-PDA Method for Simultaneous Quantification of Montelukast, Acebrophylline and Desloratadine Tablets
Corresponding Author(s) : J. Mamatha
Asian Journal of Chemistry,
Vol. 30 No. 6 (2018): Vol 30 Issue 6
Abstract
A simple, fast, accurate and specific RP-HPLC-PDA method has been developed for the simultaneous quantification of montelukast, acebrophylline and desloratadine in bulk and tablet dosage form. The chromatographic separation was performed on a reverse phase BDS C8 Column (150 × 4.6mm, 5 μm particle size) consisting mobile phase of potassium hydrogen ortho-phosphate buffer:acetonitrile (40:60 v/v), with a flow rate 1 mL/min, temperature 30 ºC and UV detection wavelength 280 nm. The retention times of montelukast, acebrophylline and desloratadine were observed as 2.04, 2.68 and 3.77 min, respectively. The developed method was validated by validation parameters such as linearity, range, accuracy, precision and robustness. The results obtained for validation parameters are within the limits as per ICH guidelines. The linearity of the drugs were obtained in the range of 5-30 ppm for montelukast, 100-600 ppm acebrophylline and 2.5-15 ppm for desloratadine. % RSD from precision studies were 0.4, 0.1 and 1.0 mean percentage recovery from accuracy studies were found to be 98.47, 98.71 and 100.11 for montelukast, acebrophylline and desloratadine respeactively. Limit of detection values were found as 0.01, 0.32 and 0.01 for montelukast, acebrophylline and desloratadine, respectively. Limit of quantification values were found as 0.03, 0.98 and 0.04 montelukast, acebrophylline and desloratadine, respectively. The method designed and validated can be successfully used for the regular quantification of montelukast, acebrophylline and desloratadine in tablet and bulk forms.
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- Indian Pharmacopoeia, The Indian Pharmacopoeia Commission: Vol II, Ministry of Health and Family Welfare, Government of India, India, pp 1704-05 (2010).
- D.S. Kumar and Y.N. Allada Narayudu, The Pharma Innov. J., 3, 54 (2014).
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- L. Liu, H. Cheng, J.J. Zhao and D.D. Rogers, J. Pharm. Biomed. Anal., 15, 631 (1997); https://doi.org/10.1016/S0731-7085(96)01894-8.
- R.M. Singh, P.K. Saini, S.C. Mathur, G.N. Singh and B. Lal, Ind. J. Pharm. Sci., 72, 235 (2010); https://doi.org/10.4103/0250-474X.65023.
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- R. Papp, P. Luk, W.M. Mullett and E. Kwong, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 858, 282 (2007); https://doi.org/10.1016/j.jchromb.2007.08.003.
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- G. Agliati, Curr. Therapeutic Res., 56, 169 (1995); https://doi.org/10.1016/0011-393X(95)85042-2.
- A.G. Susmita, G. Aruna, S. Angalaparameswari and M. Padmavathamma, Asian J. Pharm. Res., 5, 143 (2015).
- J. Maniya, H. Raj, H. Vaghani, M. Mangukiya and P. Dudhat, Indo Am. J. Pharm. Res., 2, 1027 (2012).
- S. Takkarusu, S. Thota, V.R. Kumar and V. Neerati, Res. J. Pharm. Biol. Chem. Sci., 5, 480 (2014).
- S. Ramanjaneyulu, Int. J. Inventions Pharm. Sci., 1, 404 (2013).
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- K.-D. Nam, J.-H. Seo, S.-V. Yim and K.-T. Lee, J. Pharm. Investig., 41, 309 (2011); https://doi.org/10.4333/KPS.2011.41.5.309.
- W.D.S. Solomon, M. Manu, R. Sivakumar, R. Venkatanarayanan and P.R. Vijai Anand, J. Pharm. Res., 3, 2561 (2010).
- M.L. Kharodiya, T.P. Patel, L.M. Prajapati and A.K. Joshi, World. J. Pharm. Res., 4, 1808 (2015).
- https://pubchem.ncbi.nlm.nih.gov/compound/Desloratadine.
- http://www.drugbank.ca/drugs/DB00967.
- N.V.S. Naidu and R. Challa, Int. J. Pharm. Anal. Res., 5, 294 (2016).
- A.A. Gouda and M. Kasssem, Arabian J. Chem., 9S2, S1712 (2016); https://doi.org/10.1016/j.arabjc.2012.04.050.
- R.B. Patel, M.R. Patel and J.B. Mehta, Arabian J. Chem., 10S1, S644 (2017); https://doi.org/10.1016/j.arabjc.2012.10.026.
- M. Qi, P. Wang and Y. Geng, J. Pharm. Biomed., 38, 355 (2005); https://doi.org/10.1016/j.jpba.2005.01.003.
- D.T. El-Sherbiny, N. El-Enany, F.F. Belal and S.H. Hansen, J. Pharm. Biomed. Anal., 43, 1236 (2007); https://doi.org/10.1016/j.jpba.2006.10.027.
- ICH, Q2 (R1), Harmonized Tripartite Guidelines, Validation of Analytical Procedures, Text and Methodology, London (2009)
References
Indian Pharmacopoeia, The Indian Pharmacopoeia Commission: Vol II, Ministry of Health and Family Welfare, Government of India, India, pp 1704-05 (2010).
D.S. Kumar and Y.N. Allada Narayudu, The Pharma Innov. J., 3, 54 (2014).
T. Radhakrishna, A. Narasaraju, M. Ramakrishna and A. Satyanarayana, J. Pharm. Biomed. Anal., 31, 359 (2003); https://doi.org/10.1016/S0731-7085(02)00650-7.
T.H. Hoang, R. Farkas, C. Wells, S. McClintock and M. Di Maso, J. Chromatogr. A, 968, 257 (2002); https://doi.org/10.1016/S0021-9673(02)00956-1.
L. Liu, H. Cheng, J.J. Zhao and D.D. Rogers, J. Pharm. Biomed. Anal., 15, 631 (1997); https://doi.org/10.1016/S0731-7085(96)01894-8.
R.M. Singh, P.K. Saini, S.C. Mathur, G.N. Singh and B. Lal, Ind. J. Pharm. Sci., 72, 235 (2010); https://doi.org/10.4103/0250-474X.65023.
C.J. Kitchen, A.Q. Wang, D.G. Musson, A.Y. Yang and A.L. Fisher, J. Pharm. Biomed. Anal., 31, 647 (2003); https://doi.org/10.1016/S0731-7085(02)00723-9.
R. Papp, P. Luk, W.M. Mullett and E. Kwong, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 858, 282 (2007); https://doi.org/10.1016/j.jchromb.2007.08.003.
N.S. Jadhav and K.G. Lalitha, Int. J. Pharm. Phytopharmacol. Res, 4, 113 (2014).
G. Agliati, Curr. Therapeutic Res., 56, 169 (1995); https://doi.org/10.1016/0011-393X(95)85042-2.
A.G. Susmita, G. Aruna, S. Angalaparameswari and M. Padmavathamma, Asian J. Pharm. Res., 5, 143 (2015).
J. Maniya, H. Raj, H. Vaghani, M. Mangukiya and P. Dudhat, Indo Am. J. Pharm. Res., 2, 1027 (2012).
S. Takkarusu, S. Thota, V.R. Kumar and V. Neerati, Res. J. Pharm. Biol. Chem. Sci., 5, 480 (2014).
S. Ramanjaneyulu, Int. J. Inventions Pharm. Sci., 1, 404 (2013).
R. Mohit Bauskar, Res. J. Pharm. Technol., 4, 1542 (2011).
K.-D. Nam, J.-H. Seo, S.-V. Yim and K.-T. Lee, J. Pharm. Investig., 41, 309 (2011); https://doi.org/10.4333/KPS.2011.41.5.309.
W.D.S. Solomon, M. Manu, R. Sivakumar, R. Venkatanarayanan and P.R. Vijai Anand, J. Pharm. Res., 3, 2561 (2010).
M.L. Kharodiya, T.P. Patel, L.M. Prajapati and A.K. Joshi, World. J. Pharm. Res., 4, 1808 (2015).
https://pubchem.ncbi.nlm.nih.gov/compound/Desloratadine.
http://www.drugbank.ca/drugs/DB00967.
N.V.S. Naidu and R. Challa, Int. J. Pharm. Anal. Res., 5, 294 (2016).
A.A. Gouda and M. Kasssem, Arabian J. Chem., 9S2, S1712 (2016); https://doi.org/10.1016/j.arabjc.2012.04.050.
R.B. Patel, M.R. Patel and J.B. Mehta, Arabian J. Chem., 10S1, S644 (2017); https://doi.org/10.1016/j.arabjc.2012.10.026.
M. Qi, P. Wang and Y. Geng, J. Pharm. Biomed., 38, 355 (2005); https://doi.org/10.1016/j.jpba.2005.01.003.
D.T. El-Sherbiny, N. El-Enany, F.F. Belal and S.H. Hansen, J. Pharm. Biomed. Anal., 43, 1236 (2007); https://doi.org/10.1016/j.jpba.2006.10.027.
ICH, Q2 (R1), Harmonized Tripartite Guidelines, Validation of Analytical Procedures, Text and Methodology, London (2009)