European Journal of Chemistry

Development and validation of a stability-indicating RP-LC method for the simultaneous determination of otilonium bromide and its expected degradation product in bulk drug and pharmaceutical preparation



Main Article Content

Mohamed Mahmoud El-Kerdawy
Ramzia Ismail El-Bagary
Ehab Farouk Elkady
Ahmed Adel Othman

Abstract

A simple, precise, accurate and rapid stability indicating liquid chromatography method had been developed for the simultaneous determination of otilonium bromide (OB) and its expected degradation product; p-aminobenzoic acid (PABA) in bulk powder and pharmaceutical preparation. Chromatographic separation was carried out by isocratic elution on Waters Atlantis C18 column (4.6 × 150 mm, 5 µm) using 2 mM ammonium acetate buffer (pH = 2.35) containing 0.05% TFA: acetonitrile (30:70, v:v) as the mobile phase. The flow rate was 0.8 mL/min with UV detection at 290 nm. Linearity was obtained over a concentration range of 0.5-100 μg/mL with regression coefficient of 1 for OB, and over concentration range of 1-50 μg/mL with regression coefficient of 0.9998 for PABA. The values of LOD and LOQ were found to be 0.0665 and 0.2018 μg/mL for OB and 0.1974 and 0.598 μg/mL for PABA, respectively. The method was validated as per ICH guidelines. The method was successfully applied to the determination of the drug in bulk powder and pharmaceutical preparation.


icon graph This Abstract was viewed 2088 times | icon graph Article PDF downloaded 980 times

How to Cite
(1)
El-Kerdawy, M. M.; El-Bagary, R. I.; Elkady, E. F.; Othman, A. A. Development and Validation of a Stability-Indicating RP-LC Method for the Simultaneous Determination of Otilonium Bromide and Its Expected Degradation Product in Bulk Drug and Pharmaceutical Preparation. Eur. J. Chem. 2016, 7, 97-101.

Article Details

Share
Crossref - Scopus - Google - European PMC
References

[1]. Poynard, T.; Regimbeau, C.; Benhamou, Y. Aliment. Pharm. Ther. 2001, 15(3), 355-361.
http://dx.doi.org/10.1046/j.1365-2036.2001.00937.x

[2]. Spinelli, A. Clin. Drug Invest. 2007, 27(1), 15-33.
http://dx.doi.org/10.2165/00044011-200727010-00002

[3]. Lesbros-Pantoflickova, D.; Michetti, P.; Fried, M.; Beglinger, C. Blum, A. L. Aliment. Pharm. Ther. 2004, 20(11-12), 1253-1269.
http://dx.doi.org/10.1111/j.1365-2036.2004.02267.x

[4]. Signorini, C.; Tosoni, S.; Ballerini, R.; Chinol, M.; Mannucci, C. Drug. Exp. Clin. Res. 1984, 10, 273-276.

[5]. Sutton, J. A.; Kilminster, S. G.; Mould, G. P. Eur. J. Clin. Pharmacol. 1997, 52(5), 365-369.
http://dx.doi.org/10.1007/s002280050302

[6]. Zhao, Y. R.; Ding, Li; Fan, H. W.; Yu, Y.; Qi, X. M.; Leng, Y.; Rao, Y. K. J. Chromatogr. B 2010, 878(28), 2896-2900.
http://dx.doi.org/10.1016/j.jchromb.2010.08.003

[7]. Evangelista, S.; Cochet, P.; Bromet, N.; Criscuoli, M.; Maggi, C. A. Drug. Metab. Dispos. 2000, 28(6), 643-647.

[8]. Bonanni, R.; Morocutti, A.; Nuti, A.; Pannini, S.; Mittica, V. Farmacia 1981, 6-7, 421-426.

[9]. Mannucci, C.; Bertini, J.; Cocchini, A.; Perico, A.; Salvagnini, F.; Triolo, A. J. Pharm. Sci. 1993, 82(4), 367- 370.
http://dx.doi.org/10.1002/jps.2600820406

[10]. Santoni, G.; Fabbri, L.; Mura, P.; Renzi, G.; Gratteri, P.; Pinzauti, S. Int. J. Pharm. 1991, 71(1-2), 1-5.
http://dx.doi.org/10.1016/0378-5173(91)90061-R

[11]. Kibum, K.; Haehum, J.; Hyi-Yoel, Y.; Seung-Ok, M.; Young-Ran, Y.; Kwang-il, K.; Hyesoo, K.; Soojung, S.; Wonku, K. Chromatographia 2007, 66(3-4), 257-260.
http://dx.doi.org/10.1365/s10337-007-0274-y

[12]. Shin, B. S.; Kim, J. J.; Kim. J.; Hu, S. K; Kim, H. K.; Lee, H. S.; Yoo, S. D. Arch. Pharm. Res. 2008, 31(1), 117-124.
http://dx.doi.org/10.1007/s12272-008-1129-2

[13]. Furlanetto, S.; Orlandini, S.; Massolini, G.; Faucci, M. T.; La Porta, E.; Pinzauti, S. Analyst 2001, 126(10), 1700-1706.
http://dx.doi.org/10.1039/b103091b

[14]. Morelli, B. Fresen. J. Anal. Chem. 1997, 357, 1179-1184.
http://dx.doi.org/10.1007/s002160050327

[15]. Mannucci, C.; Bertini, J.; Cocchini, A.; Perico, A.; Salvagnini, F.; Triolo, A. J. Pharm. Sci. 1992, 81(12), 1175-1177.
http://dx.doi.org/10.1002/jps.2600811209

[16]. El-Kousy, N. M.; Bebawy, L. I. J. AOAC Int. 1999, 82(3), 599-606.

[17]. Blanco, M.; Coello, J.; Iturriaga, H.; Maspoch, S.; Pou, N. Fresen. J. Anal. Chem. 2000, 368, 534-539.
http://dx.doi.org/10.1007/s002160000506

[18]. Zhao, Y; Ding, L.; Rao, Y.; Tang, X.; Ding, J. J. China Pharm. Univ. 2010, 41(6), 548-554.

[19]. De Ruiter, J. Amides and Related Functional Groups. In: Principles of Drug Action 1, Spring, 2005.

[20]. Snyder, L.; Kirkland, J. and Glajch, J. Ed.; Wiley- Interscience New York, Chichester, Brisbane, Toronto, Singapore, 1988.

[21]. ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2(R1), Current Step 4 Version, Parent Guidelines on Methodology Dated November 6 1996, Incorporated in November 2005.

Supporting Agencies

Minapharm Co, Egypt
Most read articles by the same author(s)

Most read articles by the same author(s)

TrendMD

Dimensions - Altmetric - scite_ - PlumX

Downloads and views

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...
License Terms

License Terms

by-nc

Copyright © 2024 by Authors. This work is published and licensed by Atlanta Publishing House LLC, Atlanta, GA, USA. The full terms of this license are available at https://www.eurjchem.com/index.php/eurjchem/terms and incorporate the Creative Commons Attribution-Non Commercial (CC BY NC) (International, v4.0) License (http://creativecommons.org/licenses/by-nc/4.0). By accessing the work, you hereby accept the Terms. This is an open access article distributed under the terms and conditions of the CC BY NC License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited without any further permission from Atlanta Publishing House LLC (European Journal of Chemistry). No use, distribution, or reproduction is permitted which does not comply with these terms. Permissions for commercial use of this work beyond the scope of the License (https://www.eurjchem.com/index.php/eurjchem/terms) are administered by Atlanta Publishing House LLC (European Journal of Chemistry).