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Abstrakty
A simple, selective, and sensitive thin-layer chromatographic—densitometric method has been developed for the determination of sulfasalazine besides its possible impurities in pharmaceutical preparations. The mobile phase was composed of ethyl acetate—methanol—ammonia 25% 10:7:3 (υ/υ/υ), and the stationary phase was aluminum plates precoated with silica gel 60 F254 that enabled to obtain well resolved peaks of sulfasalazine and its impurities. The developed chromatograms were analyzed densitometrically at λ = 360 nm. RF values and ultraviolet (UV) spectra were used to identify the compounds. The developed method is highly sensitive (limit of detection [LOD] = 17.11 ng spot−1, limit of quantitation [LOQ] = 51.84 ng spot−1), precise (relative standard deviation [RSD] = 1.43%–4.28%), and accurate (RSD = 1.64%–4.27%). The linearity of the method was checked within the range 20–120 ng spot−1. The method was successfully applied for the determination of sulfasalazine in pharmaceutical preparations besides its impurities. The structures of impurities present in the standard substance and in pharmaceutical preparations were established by ultra-performance liquid chromatography—tandem mass spectrometry (UPLC—MS/MS) technique.
Słowa kluczowe
Czasopismo
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Tom
Strony
623--635
Opis fizyczny
Bibliogr. 11 poz., rys., tab.
Twórcy
autor
- Department of Inorganic and Analytical Chemistry, Jagiellonian University, Medical College, Faculty of Pharmacy, Medyczna 9, 30-688, Kraków, Poland
autor
- Department of Inorganic and Analytical Chemistry, Jagiellonian University, Medical College, Faculty of Pharmacy, Medyczna 9, 30-688, Kraków, Poland
autor
- Department of Inorganic and Analytical Chemistry, Jagiellonian University, Medical College, Faculty of Pharmacy, Medyczna 9, 30-688, Kraków, Poland
autor
- Department of Inorganic and Analytical Chemistry, Jagiellonian University, Medical College, Faculty of Pharmacy, Medyczna 9, 30-688, Kraków, Poland
Bibliografia
- [1] N. Pastor-Navarro, E. Gallego-Iglesias, A. Maquieira, and R. Puchades, Anal. Chim. Acta, 583, 377 (2007)
- [2] Polish Pharmacopoeia, 9th edn., Warszawa, 2011
- [3] G.L. Plosker and K.F. Croom, Drugs, 65, 1825 (2005)
- [4] http: //www.liversupport.com/wordpress/2011/09/new-angle-for-tackling-liverfibrosis/
- [5] R. Chauhan and S. Virmani, Int. J. Pharm. Sci. Rev. Res., 15, 120 (2012)
- [6] N.M. El-Guindi, B.M. Abbas, R.I. El-Bagary, and E.A. Amer, J. Chem. Pharm. Res., 3, 412 (2011)
- [7] G.Z. Gu, H.M. Xia, Z.Q. Pang, Z.Y. Liu, X.G. Jiang, and J. Chen, J. Chromatogr. B, 879, 449 (2011)
- [8] S. Sadeghi, A. Motaharian, and A.Z. Moghaddam, Sensor. Actuat. B, 168, 336 (2012)
- [9] G. Font, A. Juan-Garcia, and Y. Pico, J. Chromatogr. A, 1159, 233 (2007)
- [10] ICH Guideline Q2(R1) on Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, 6 Nov. 1996, incorp. Nov. 2005, Geneva
- [11] K. Ferenczi-Fodor, B. Renger, and Z. Végh, J. Planar Chromatogr., 23, 173 (2010)
Typ dokumentu
Bibliografia
Identyfikator YADDA
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