European Journal of Chemistry

Development and validation of stability indicating spectrophotometric and HPTLC methods for determination of acemetacin



Main Article Content

Ibrahim Ahmed Naguib
Eglal Abdelhamid Abdelaleem
Hala Elsayed Zaazaa
Essraa Abd ElWahab Hussein

Abstract

Three simple and sensitive methods were developed for the determination of acemetacin (ACM) in presence of its degradation product, indomethacin (DEG). Several methods were evaluated and are presented. Method A was based on measuring the peak amplitude of the first derivative of the ratio spectra 1DD at 244 nm. In method B, mean centering of ratio spectra method (MCR) was applied, which depends on measuring the mean centered values of ratio spectra of ACM at 234 nm. Method C provided separation of ACM from its DEG on pre-activated silica gel 60F254 HPTLC plates using hexane:ethyl acetate:glacial acetic acid (6:4:0.3, v:v:v) as developing system followed by scanning at 254 nm. The suggested methods were validated in compliance with the International Conference on Harmonisation (ICH) guidelines and were successfully applied for quantification of ACM in its commercial capsule. The proposed methods were also statistically compared to a reported HPLC method with no significant difference in performance; indicating the ability of the proposed method to be reliable and suitable for routine analysis of drug product.


icon graph This Abstract was viewed 1639 times | icon graph Article PDF downloaded 748 times

How to Cite
(1)
Naguib, I. A.; Abdelaleem, E. A.; Zaazaa, H. E.; Hussein, E. A. E. Development and Validation of Stability Indicating Spectrophotometric and HPTLC Methods for Determination of Acemetacin. Eur. J. Chem. 2014, 5, 219-226.

Article Details

Share
Crossref - Scopus - Google - European PMC
References

[1]. Maryedele, J. O'Neil, The Merck Index, An Encyclopedia of Chemicals, Drugs and Biologicals, 14th ed., Merck and Co. Inc., Whitehouse Station, NJ, USA.

[2]. Reynolds, J. E. F., Martindale, The Extra Pharmacopoeia. Thirsty-first ed.; Royal Pharmaceutica Society: London, 1996.

[3]. Li, D. M.; Lu, W. L.; Wang, X. Q.; Wang, J. C.; Zhang, H.; Zhang, R. J.; Wang, G.L.; Zhang, X.; Zhang, Q. J. Health Sci. 2005, 51(3), 308-316.
http://dx.doi.org/10.1248/jhs.51.308

[4]. Ozbakan, H.; Palabiyik, I. M.; Caglayan, M. G.; Feyyaz, O. Turk J. Pharm. Sci. 2009, 6(3), 163-176.

[5]. Escuder-Gilabert, L.; Martin-Biosca, Y.; Sagrado, S.; Villanueva-Camanas, R.; Medina-Hernandez, M. Chromatographia 2002, 55(5-6), 283-288.
http://dx.doi.org/10.1007/BF02491660

[6]. Castro, B.; Gameiro, P.; Lima, J. L.; Matos, C.; Reis, S. Mater. Sci. Eng. C 2001, 18(1), 71-78.
http://dx.doi.org/10.1016/S0928-4931(01)00372-1

[7]. Arcos, M. J.; Ortiz, M. C.; Villahoz, B. N.; Sarabia, L. A. Anal. Chim. Acta 1997, 339(1), 63-77.
http://dx.doi.org/10.1016/S0003-2670(96)00438-2

[8]. Pang, J.; Hengshan, T. Zhongguo Yiyuan Yaoxue Zazhi 2004, 24(4), 246-247.

[9]. Shi, X.; Chen, M.; Zhang, J.; Zhang, L.; Wang, H. Zhongguo Yiyao Zazhi 2001, 32(10), 454-456.

[10]. Hu, Y. Q.; Liu, H. C.; Ma, R.; Wang, J.; Hou, Y. N. Se Pu 1999, 17(6), 586-587.

[11]. Reguera, C.; Julia Arcos, M.; Cruz Ortiz, M. Talanta 1998, 46(6), 1493-1505.
http://dx.doi.org/10.1016/S0039-9140(98)00024-1

[12]. Chavez-Pina, W. M.; Dicay, M.; Castaneda-Hernandez, G.; Wallace, J.L. Brit. J. Pharmacol. 2007, 152(6), 930-938.
http://dx.doi.org/10.1038/sj.bjp.0707451

[13]. Saul PA, K. K. Curr. Med. Res. Opin. 1991, 12(5), 332-341.
http://dx.doi.org/10.1185/03007999109112669

[14]. Bakshi, M.; Singh, S. J. Pharmaceut. Biomed. 2002, 28(6), 1011-1040.
http://dx.doi.org/10.1016/S0731-7085(02)00047-X

[15]. Donald, L. P.; George S. K. Introduction to Spectroscopy. Western Washington University: Bellingham, Washington, USA, 2009.

[16]. Afkhami, A.; Bahram, M. Anal. Chim. Acta 2004, 526(2), 211-218.
http://dx.doi.org/10.1016/j.aca.2004.09.064

[17]. Afkhami, A.; Bahram, M. Talanta 2005, 66(3), 712-720.
http://dx.doi.org/10.1016/j.talanta.2004.12.004

[18]. Afkhami, A.; Bahram, M. Talanta 2006, 68(4), 1148-1155.
http://dx.doi.org/10.1016/j.talanta.2005.07.017

[19]. Desai, N.; Amin, P. I. J. Pharm. Sci. 2008, 70(5), 644-647.

[20]. ICH, Q2 (R1) Validation of Analytical Procedures: Text and Methodology, ICH Harmonized Tripartite Guideline, 2005. Guideline, I.H.T., Validation of Analytical Procedures: Text and Methodology, Q2 (R1) Geneva, 2005.

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).