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Simultaneous Quantification of Formoterol Fumarate and Glycopyrrolate Using Reverse Phase High Performance Liquid Chromatography
Corresponding Author(s) : Anandan Kalaiselvan
Asian Journal of Chemistry,
Vol. 30 No. 11 (2018): Vol 30 Issue 11
Abstract
A fully validated and rapid RP-HPLC method suitable for the quantification of formoterol fumarate and glycopyrrolate combination is reported. Chromatographic separation was achieved on a Sunsil C18 analytical column (250 mm × 4.6 mm, 5 μ particle size). The analytes were detected and quantified by photodiode array detector set at 289 nm. Calibration curves were constructed in the range of 4.8-14.4 μg/mL (R2 = 0.9997) with a limit of quantification of 0.279 μg/mL for formoterol fumarate and 9-27 μg/mL (R2 = 0.9998) with a limit of quantification 0.239 μg/mL for glycopyrrolate. The method was validated aaccording to ICH guidelines. The developed and validated RP-HPLC method was sensitive, selective, robust, accurate and precise for the simultaneous estimation of formoterol fumarate and glycopyrrolate in quality control laboratories.
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- R.A. Bartow and R.N. Brogden, Drugs, 55, 303 (1998); https://doi.org/10.2165/00003495-199855020-00016.
- W.E. Berger, Ann. Allergy Asthma Immunol., 97, 24 (2006); https://doi.org/10.1016/S1081-1206(10)61365-8.
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- British pharmacopoeia, Medicines and Health care Products regulatory Agency London, p. 965 (2008).
- S.P. Aashish, D.F. Sandip and J.S. Sanjay, Anal. Chem. Indian J., 16, 1 (2016).
- Md. Gousuddin, S.A. Raju, Md. Sultanuddin and M. Shobha, Int. J. Pharm. Pharm. Sci., 3, 306 (2011).
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W.E. Berger, Ann. Allergy Asthma Immunol., 97, 24 (2006); https://doi.org/10.1016/S1081-1206(10)61365-8.
Indian Pharmacopoeia, Ministry of Health and Family Welfare, Government of India, New Delhi, p. 1145 (2007).
British pharmacopoeia, Medicines and Health care Products regulatory Agency London, p. 965 (2008).
S.P. Aashish, D.F. Sandip and J.S. Sanjay, Anal. Chem. Indian J., 16, 1 (2016).
Md. Gousuddin, S.A. Raju, Md. Sultanuddin and M. Shobha, Int. J. Pharm. Pharm. Sci., 3, 306 (2011).
D. Taþkin, G. Erensoy and S. Sungur, Marmara Pharm. J., 20, 275 (2016); https://doi.org/10.12991/mpj.20162030844.
S.O. Akapo and M. Asif, J. Pharm. Biomed. Anal., 33, 935 (2003); https://doi.org/10.1016/S0731-7085(03)00425-4.
S.A. Raju, Md. Gousuddin, S.A. Raju, Md. Sultanuddin and M. Shobha, Int. J. Biol. Adv. Res., 2, 18 (2011).
S. Ahmed, B. Jayakar and M.A. Aleem, Int. J. Pharm. Sci. Res., 2, 319 (2011); https://doi.org/10.13040/IJPSR.0975-8232.2(2).319-24.
J. Campestrini, J.B. Lecaillon and J. Godbillon, J. Chromatogr. B. Biomed. Sci. Appl., 704, 221 (1997); https://doi.org/10.1016/S0378-4347(97)00425-8.
P. Ashish, Int. J. Adv. Pharma. Anal., 5, 80 (2015).
D.G. Mascher, K. Zech, R. Nave, K.M. Kubesch and H.J. Mascher, J. Chromatogr. B. Analyt. Technol. Biomed. Life. Sci., 830, 25 (2006); https://doi.org/10.1016/j.jchromb.2005.10.022.
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G. He, J. Lu, X. Wang, Y. Xu, Y. Wu, Y. Dong, L. Shen, Z. He, J. Zhao and H. Yuan, J. Chromatogr. Sci., 52, 848 (2014); https://doi.org/10.1093/chromsci/bmt127.
E. Sener, M. Tunçel and H.Y. Aboul-Enein, Arch. Pharm., 336, 226 (2003); https://doi.org/10.1002/ardp.200300733.
J.Z., Song, J. Chen, S.J. Tian and Z.P. Sun, J. Pharm. Biomed. Anal., 21, 569 (1999); https://doi.org/10.1016/S0731-7085(99)00158-2.
B.T. Demircigil, S.A. Ozkan, O. Coruh and S. Yilmaz, Electroanalysis, 14, 122 (2002); https://doi.org/10.1002/1521-4109(200201)14:2<122::AID-ELAN122>3.0.CO;2-1.
J. Howard, J. Wigley, G. Rosen and J. D’mello, J. Clin. Anesth., 36, 51 (2017); https://doi.org/10.1016/j.jclinane.2016.09.013.
H.H. Lee, D.W. Kim, D.W. Kim and C. Kim, Korean J. Pain, 25, 28 (2012); https://doi.org/10.3344/kjp.2012.25.1.28.
Indian Pharmacopoeia, Government of India. Ministry of Health and Family Welfare New Delhi, vol. II, p. 1278 (2007).
United States Pharmacopoeia, Asian Edition, United Pharmacopoeial Convention Inc.: Rockville, USA, p. 2386 (2005).
G. Kumaraswamy, P. Parameshwar and A. Ganesh, J. Asian Pharm. Clin. Res., 4, 37 (2011).
S. Mishra and V. Arora, Int. J. Pharm. Res. Sch., 5, 101 (2016).
S.C. Sohan, S.J. Hitesh, R.C. Sneha and P.G. Sejal, Inventi Impact: Pharm. Anal. Qual. Assur., 171 (2015).
M.L. Storme, R.S. t’Kindt, W. Goeteyn, K. Reyntjens and J.F. Van Bocxlaer, J. Chromatogr. B. Analyt. Technol. Biomed. Life. Sci., 876, 24 (2008); https://doi.org/10.1016/j.jchromb.2008.10.013.
M.J. Rumpler, R.A. Sams and P. Colahan, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 889–890, 130 (2012); https://doi.org/10.1016/j.jchromb.2012.02.008.
M.J. Rumpler, R.A. Sams and P. Colahan, J. Anal. Toxicol., 35, 656 (2011); https://doi.org/10.1093/anatox/35.9.656.
L.C. Matassa, D. Woodard, R.K. Leavitt, P. Firby and P. Beaumier, J. Chromatogr. B Biomed. Sci. Appl., 573, 43 (1992); https://doi.org/10.1016/0378-4347(92)80472-3.
L. Zuo, Y. Zhao, F. Ji, M. Zhao, Z. Jiang, T. Sun and X. Guo, Electrophoresis, 35, 3339 (2014); https://doi.org/10.1002/elps.201400170.
D. Radovanovic, M. Mantero, G.F.S. Papa, V. Valenti, S. Aliberti, F. Di Marco and P. Santus, Expert. Rev. Respir. Med., 10, 1045 (2016); https://doi.org/10.1080/17476348.2016.1227247.
C. Reisner, L.M. Fabbri, E.M. Kerwin, C. Fogarty, S. Spangenthal, K.F. Rabe, G.T. Ferguson, F.J. Martinez, J.F. Donohue, P. Darken, E. St Rose, C. Orevillo, S. Strom, T. Fischer, M. Golden and S. Dwivedi, Respir. Res., 18, 8 (2017); https://doi.org/10.1186/s12931-016-0491-8.
N. Md Akram and M. Umamahesh, World J. Pharm. Pharm. Sci., 6, 903 (2017).
International Conference on Harmonization, ICH Guidelines, Validation of Analytical Procedures Technical Requirements for Registration of Pharmaceuticals for Human Use: Text and Methodology Q 2 (R1), International Conference on Harmonization, Geneva, Switzerland (2005).