OPEN ACCESS | PEER-REVIEWED | RESEARCH ARTICLE | DOWNLOAD PDF | VIEW FULL-TEXT PDF | TOTAL VIEWS
Quantitative determination of clobetasone butyrate in bulk and cream formulation by a validated stability-indicating reversed-phase HPLC method
Hassan Ahmad Alhazmi (1,*) , Gunasekar Manoharan (2) , Mohammed Al Bratty (3) , Sadique Akhtar Javed (4)
(1) Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, 45142, Kingdom of Saudi Arabia
(2) Chemistry Department, Faculty of Science, Jazan University, Jazan, 45142, Kingdom of Saudi Arabia
(3) Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, 45142, Kingdom of Saudi Arabia
(4) Department of Pharmaceutical Chemistry, College of Pharmacy, Jazan University, Jazan, 45142, Kingdom of Saudi Arabia
(*) Corresponding Author
Received: 08 Mar 2018 | Revised: 11 Apr 2018 | Accepted: 18 Apr 2018 | Published: 30 Jun 2018 | Issue Date: June 2018
A simple isocratic reversed-phase HPLC method for quantification of clobetasone in bulk and cream dosage forms has been developed. Chromatographic analysis was accomplished on an C18 column utilizing a mixture of methanol and water (84:16 v:v, pH = 6.0) as mobile phase. An effluent flow rate of 1 mL/min was adjusted and the detection was made at 240 nm wavelength. The method was evaluated according to ICH guidelines Q2 R1 for linearity, specificity, sensitivity, precision and accuracy. The method exhibited good linearity with correlation coefficient (r2) of 0.9993 over the concentration range from 5 to 50 μg/mL. The recoveries of the test drug from the cream sample was found to be 98.56 to 99.51% and the limit of detection and quantification were calculated as 0.85 and 2.83 μg/mL, respectively, suggesting the accuracy and sensitivity of the developed method. The precision was demonstrated by a low percentage of relative standard deviation (<1%) from six independent assay analysis performed for the cream formulation. Stability indicating property of the proposed method was demonstrated by performing the analysis of forced degradation samples. The developed method can be used for estimation of the clobetasone butyrate in bulk and pharmaceutical formulations for routine analysis in the quality control laboratories.
Links for Article
| | | | | | |
| | | | | | |
Article MetricsThis Abstract was viewed 569 times | PDF Article downloaded 288 times
. Munro, D. D.; Wilson, L. Br. Med. J. 1975, 3, 626-628.
. Ramsell, T. G.; Bartholomew, R. S.; Walker, S. R. Br. J. Ophthalmol. 1980, 64, 43-45.
. British Pharmacopoeia. International edition, Vol. I & II, HMSO, London, 2009, pp. 1171-1245.
. Gagliardi, L.; Orsi, D. D.; Manna, F.; Tonelli, D. J. Liq. Chromatogr. Rel. Technol. 2000, 23, 355-362.
. Goustas, P.; Cork, M. J.; Higson, D. J. Dermatolog. Treat. 2003, 14, 71-85.
. Parneix-Spake, A.; Goustas, P.; Green, R. J. Dermatolog. Treat. 2001, 12, 191-197.
. Williamson, J.; Eilon, L. A.; Walker, S. R. Trans. Ophthalmol. Soc. U.K. 1981, 101, 27-29.
. Patel, A. G.; Patel, R. B.; Patel, M. R. J. Assoc. Off. Anal. Chem. 1990, 73, 893-895.
. Kamberi, M.; Fu, K.; Lu, J.; Chemaly, G. M.; Feder, D. J. Chromatogr. Sci. 2008, 46, 23-29.
. Fontana, M. C.; Bastos, M. O.; Beck, R. C. R. J. Chromatogr. Sci. 2010, 48, 637-640.
. Fauzee, A. F.; Walker, R. B. J. Sep. Sci. 2013, 36, 849-856.
. Musmade, P. B.; Deshpande, P. B.; Dengle, S. J.; Talole, K. B.; Pathak, S. M.; Adiga, M. N. S.; Bhat, K.; Udupa, N.; Bairy, K. L. J. Bioanal. Biomed. 2010, 2, 1-7.
. Badilli, U.; Amasya, G.; Ozkan, S.; Tarimci, N. Chromatographia 2013, 76, 133-140.
. International Conference on Harmonization (ICH). (2005). Validation of Analytical Procedures: Text and Methodology, Q2 (R1). http://www.ipqpubs.com/wp-content/uploads/2011/09/Q2_R1_Guideline.pdf (accessed on 14 November 2017).
How to cite
The other citation formats (EndNote | Reference Manager | ProCite | BibTeX | RefWorks) for this article can be found online at: How to cite item
DOI Link: https://doi.org/10.5155/eurjchem.9.2.92-98.1700
| | | | | | |
| | | | | |
Save to Zotero Save to Mendeley
European Journal of Chemistry 2018, 9(2), 92-98 | doi: https://doi.org/10.5155/eurjchem.9.2.92-98.1700 | Get rights and content
- There are currently no refbacks.
Copyright (c) 2018 Authors
This work is published and licensed by Atlanta Publishing House LLC, Atlanta, GA, USA. The full terms of this license are available at http://www.eurjchem.com/index.php/eurjchem/pages/view/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 (http://www.eurjchem.com/index.php/eurjchem/pages/view/terms) are administered by Atlanta Publishing House LLC (European Journal of Chemistry).
© Copyright 2010 - 2020 • Atlanta Publishing House LLC • All Right Reserved.
The opinions expressed in all articles published in European Journal of Chemistry are those of the specific author(s), and do not necessarily reflect the views of Atlanta Publishing House LLC, or European Journal of Chemistry, or any of its employees.
Copyright 2010-2020 Atlanta Publishing House LLC. All rights reserved. This site is owned and operated by Atlanta Publishing House LLC whose registered office is 2850 Smith Ridge Trce Peachtree Cor GA 30071-2636, USA. Registered in USA.