Copyright (c) 2017 AJC
This work is licensed under a Creative Commons Attribution 4.0 International License.
A Submicellar Liquid Chromatographic Method for Quantitative Determination of Muscle Relaxant Drug Baclofen in Solubilized System
Corresponding Author(s) : Ashok Kumar
Asian Journal of Chemistry,
Vol. 29 No. 7 (2017): Vol 29 Issue 7
Abstract
A high performance liquid chromatography method, using micellar solution above the critical micellar concentration (CMC) has been developed and validated to quantify baclofen (a muscle relaxant drug) in active pharmaceutical ingredients and pharmaceutical formulations. Process optimization was done at various conditions such as different surfactants, surfactant concentration, pH of buffer solution, solvent composition, solvent selection and different HPLC columns. An isocratic HPLC mode, column temperature 35 °C, Intersil ODS-3 V 250 × 4.6, 5 μm column, 0.8 mL/min mobile phase flow rate and UV detection wavelength at 220 nm was used for the purpose. The method was validated as per International Conference on Harmonization (ICH) guidelines viz., specificity, linearity, range, inter and intra-day precision, accuracy (recovery) and robustness. Forced degradation conditions such as basic, acidic, oxidative, thermal degradation and photolytic are applied to prove the stability indicating nature of the proposed method.
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- R.E. Cochran, N. Dongari, H. Jeong, J. Beránek, S. Haddadi, J. Shipp and A. Kubátova, Anal. Chim. Acta, 740, 93 (2012); https://doi.org/10.1016/j.aca.2012.05.050.
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- British Pharmacopeia, The Stationary office, London (2015).
- European Pharmacopeia Commission, 8th Edition, Council of Europe, Strasbourg (2014).
- United States Pharmacopeia, 39th Edition, NF-34. USA (2016).
- I.R. Miksa and R.H. Poppenga, J. Anal. Toxicol., 27, 275 (2003); https://doi.org/10.1093/jat/27.5.275.
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References
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M.J. Ruiz-angel, J.R. Torres-Lapasio, M.C. Garcia-Alvarez-Coque and S. Carda-Broch, Anal. Chem., 80, 9705 (2008); https://doi.org/10.1021/ac801685p.
B.K. Lavine, S. Hendayan, W.T. Cooper and Y. He, ACS Symp. Ser., 740, 290 (1999); https://doi.org/10.1021/bk-2000-0740.ch018.
A. Berthod, I. Girard and C. Gonnet, Anal. Chem., 58, 1362 (1986); https://doi.org/10.1021/ac00298a021.
A. Berthod and A. Roussel, J. Chromatogr. A, 449, 349 (1988); https://doi.org/10.1016/S0021-9673(00)94400-5.
A. Berthod, M.F. Borgerding and W.L. Hinze, J. Chromatogr. A, 556, 263 (1991); https://doi.org/10.1016/S0021-9673(01)96226-0.
A. Berthod and M.C. Garcia-Alvarez-Coque, Micellar Liquid Chromatography, Marcel Dekker, New York (2000).
M.J. Ruiz-Angel, M.C. Garcia-Alvarez-Coque and A. Berthod, Sep. Purif. Rev., 38, 45 (2009); https://doi.org/10.1080/15422110802178876.
J. Ong and D.I.B. Kerr, CNS Drug Rev., 11, 317 (2005); https://doi.org/10.1111/j.1527-3458.2005.tb00049.x.
G. Addolorato, F. Caputo and E. Capristo, Alcohol, 37, 504 (2002); https://doi.org/10.1093/alcalc/37.5.504.
G. Addolorato, L. Leggio, A. Ferrulli, S. Cardone, L. Vonghia, A. Mirijello, L. Abenavoli, C. D’Angelo, F. Caputo, A. Zambon, P.S. Haber and G. Gasbarrini, Lancet, 370, 1915 (2007); https://doi.org/10.1016/S0140-6736(07)61814-5.
A. Buda-Levin, F.H.E. Wojnicki and R.L. Corwin, Physiol. Behav., 86, 176 (2005); https://doi.org/10.1016/j.physbeh.2005.07.020.
R.N. Brogden, T.M. Speight and G.S. Avery, Drugs, 8, 1 (1974); https://doi.org/10.2165/00003495-197408010-00001.
R.J. Tyacke, A. Lingford-Hughes, L.J. Reed and D.J. Nutt, Adv. Pharmacol., 58, 373 (2010); https://doi.org/10.1016/S1054-3589(10)58014-1.
B. Rolland, R. Bordet and O. Cottencin, Addiction, 107, 848 (2012); https://doi.org/10.1111/j.1360-0443.2011.03752.x.
I. Lidums, A. Lehmann, H. Checklin, J. Dent and R.H. Holloway, Gastroenterology, 118, 7 (2000); https://doi.org/10.1016/S0016-5085(00)70408-2.
K. Yomiya, N. Matsuo, S. Tomiyasu, T. Yoshimoto, T. Tamaki, T. Suzuki and M. Matoba, Am. J. Hosp. Palliat. Med., 26, 112 (2009).
M.C. Taylor and C.P. Bates, Br. J. Urol., 51, 504 (1979); https://doi.org/10.1111/j.1464-410X.1979.tb03588.x.
C. Herdeis and H.P. Hubmann, Tetrahedron Asymm., 3, 1213 (1992); https://doi.org/10.1016/S0957-4166(00)82107-2.
F. Xu, G. Peng, T. Phan, U. Dilip, J.L. Chen, T. Chernov-Rogan, X. Zhang, K. Grindstaff, T. Annamalai, K. Koller, M.A. Gallop and D.J. Wustrow, Bioorg. Med. Chem. Lett., 21, 6582 (2011); https://doi.org/10.1016/j.bmcl.2011.08.006.
British Pharmacopeia, The Stationary office, London (2015).
European Pharmacopeia Commission, 8th Edition, Council of Europe, Strasbourg (2014).
United States Pharmacopeia, 39th Edition, NF-34. USA (2016).
I.R. Miksa and R.H. Poppenga, J. Anal. Toxicol., 27, 275 (2003); https://doi.org/10.1093/jat/27.5.275.
S. Jain, N.K. Jain and K.S. Pitre, J. Pharm. Biomed. Anal., 31, 1035 (2003); https://doi.org/10.1016/S0731-7085(02)00700-8.
B.K. Lavine and S. Hendayana, J. Liq. Chromatogr. Relat. Technol., 19, 101 (1996); https://doi.org/10.1080/10826079608006292.
ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures, Text and Methodologies Q2 (R1).
Validation of Compendia Methods, United States Pharmacopeia, 39th Edition (2016).