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Optimization of RP-Gradient-HPLC Method for Evaluation of Impurities of Scopolamine from Transdermal Delivery Patch
Corresponding Author(s) : Galla Vamsi Krishna
Asian Journal of Chemistry,
Vol. 30 No. 4 (2018): Vol 30 Issue 4
Abstract
A new reversed phase gradient-HPLC method is developed for evaluation of impurities of scopolamine from transdermal delivery patch formulation, prescribed to treat addiction-related disorders. Selection of stationary phase and chromatographic conditions were discussed regarding separation efficiency and gradient consistency of the newly developed method. Challenges related to extraction of impurities along with active ingredient from inactive polymer matrix which contain multiple layers and coatings were fully addressed. The method is developed by using Inertsil ODS-3V column with phosphate buffer (pH 5.5) as aqueous phase and combination of acetonitrile and methanol as organic modifier. At flow rate of 0.7 mL/min with linear gradient, scopolamine and its related impurities namely Imp-A, B, C and D were monitored at the wavelength of 210 nm. The finalized chromatographic conditions and test methodology is verified as per ICH Q2 (R1) guideline. Linearity and accuracy of the method was found to be within the range of LOQ to 150 % with correlation coefficient (r) of 0.999 ± 5 %.
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N. Hosseini, S.N. Ebrahimi, P. Salehi, B. Asghari and M. Ahmadi, J. Med. Plants Res., 5, 15 (2011).
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A. Bahmanzadegan, F. Sefidkon and A. Sonboli, Iran. J. Pharm. Res., 8, 65 (2009).
M.A. Fliniaux, F. Manceau and A. Jacquin-Dubreuil, J. Chromatogr. A, 644, 193 (1993); https://doi.org/10.1016/0021-9673(93)80130-Z.
S. Mandal, A. Naqvi and R.S. Thakur, Phytochem. Anal., 2, 208 (1991); https://doi.org/10.1002/pca.2800020505.
K.H. Plank and K.G. Wagner, Z. Naturforsch. B, 41c, 391 (1986).
M. Masrournia, Z. Es’haghi and M. Amini, Am. J. Anal. Chem., 2, 235 (2011); https://doi.org/10.4236/ajac.2011.22028.
L.J. Pennington and W.F. Schmidt, J. Pharm. Sci., 71, 951 (1982); https://doi.org/10.1002/jps.2600710830.
R.O. Zimmerer Jr. and L.T. Grady, J. Pharm. Sci., 59, 87 (1970); https://doi.org/10.1002/jps.2600590115.
J.J. Windheuser, J.L. Sutter and A. Sarrif, J. Pharm. Sci., 61, 1311 (1972); https://doi.org/10.1002/jps.2600610831.
M. Kartal, S. Kurucu, L. Altun, T. Ceyhan, E. Sayar, S. Cevheroglu and Y. Yetkin, Turk. J. Chem., 27, 565 (2003).
N.W Ali, M. Gamal, M. Abdelkawy, Pharm. Anal. Acta, S7, 006 (2013); https://doi.org/10.4172/2153-2435.S7-006.
P. Zhang, Y. Li, G. Liu, X. Sun, Y. Zhou, X. Deng, Q. Liao and Z. Xie, J. Sep. Sci., 37, 2664 (2014); https://doi.org/10.1002/jssc.201400534.
J. Beyer, F.T. Peters, T. Kraemer and H.H. Maurer, J. Mass Spectrom., 42, 621 (2007); https://doi.org/10.1002/jms.1191.
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S. Berkov and A. Pavlov, Phytochem. Anal., 15, 141 (2004); https://doi.org/10.1002/pca.756.
N.M. Cintron and Y.M. Chen, J. Pharm. Sci., 76, 328 (1987); https://doi.org/10.1002/jps.2600760413.
I.N. Papadoyannis, V.F. Samanidou, G.A. Theodoridis, G.S. Vasilikiotis, G.J.M. Van Kempen and G.M. Beelen, J. Liq. Chromatogr., 16, 975 (1993); https://doi.org/10.1080/10826079308019565.
ICH, Validation of Analytical Procedure: Text and Methodology Q2 (R1), In: International Conference on Harmonization (2005).