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2013 | Vol. 25, no. 4 | 711--724
Tytuł artykułu

Stress degradation studies on aliskiren and the development of a sensitive stability-indicating MEKC method

Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A sensitive, fast, and stability-indicating micellar electrokinetic chromatographic (MEKC) method was developed and validated for the analysis of aliskiren (ALI) in tablets using nimesulide as internal standard (IS). Optimal conditions for the separation of ALI and its degradation products were investigated. The method employed 60 mM Tris buffer and 50 mM anionic detergent sodium dodecyl sulfate (SDS) solution at pH 9.8. MEKC method was performed on a fused-silica capillary (50 μm id; effective length, 40 cm). The capillary temperature was maintained at 35°C, and the applied voltage was 30 kV, with detection by photodiode array (PDA) detector set at 204 nm. The method was validated in accordance with the International Conference on Harmonisation (ICH) requirements. The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using PDA detection. The method was linear over the concentration range of 5–150 μg mL -1 (r2 = 0.9996) of ALI. Intraday and interday precision and accuracy evaluated by relative standard deviation, respectively, were lower than 2%. The limit of detection was 1.31 μg mL -1. The method proved to be robust by a one-variable-at-a-time evaluation. The proposed MEKC method was successfully applied for the quantitative analysis of ALI in tablets to support the quality control.
Wydawca

Rocznik
Strony
711--724
Opis fizyczny
Bibliogr. 22 poz., rys., tab.
Twórcy
  • Federal University of Rio Grande do Sul Faculty of Pharmacy 90610-000 Porto Alegre-RS Brazil, maxsilvasangoi@yahoo.com.br
  • Federal University of Rio de Janeiro Faculty of Pharmacy 27930-560 Macaé-RJ Brazil
  • Federal University of Santa Maria Department of Industrial Pharmacy 97105-900 Santa Maria-RS Brazil
  • Federal University of Rio Grande do Sul Faculty of Pharmacy 90610-000 Porto Alegre-RS Brazil
  • Federal University of Santa Maria Department of Industrial Pharmacy 97105-900 Santa Maria-RS Brazil
Bibliografia
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  • [9] M. Wrasse-Sangoi, M.S. Sangoi, P.R. Oliveira, L.T. Secretti, and C.M.B. Rolim, J. Chromatogr. Sci., 49, 170 (2011)
  • [10] M. Wrasse-Sangoi, L.T. Secretti, I.F. Diefenbach, C.M.B. Rolim, and M.S. Sangoi, Quim. Nova, 33(6), 1330 (2010)
  • [11] M.S. Sangoi, M. Wrasse-Sangoi, P.R. Oliveira, V. Todeschini, and C.M.B. Rolim, J. Liq. Chromatogr. Relat. Technol., 34, 1976 (2011)
  • [12] M.S. Sangoi, M. Wrasse-Sangoi, P.R. Oliveira, C.M.B. Rolim, and M. Steppe, J. Sep. Sci., 34, 1859 (2011)
  • [13] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Stability testing of New Drug Substances and Products, Q1A(R2), Geneva, August, 2003
  • [14] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Text and Methodology, Q2(R1), Geneva, November, 2005
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  • [17] United States Pharmacopeial Convention, The United States Pharmacopeia, 32th ed., Rockville, MD, 2009
  • [18] K.L. See, A.A. Elbashir, B. Saad, A.S.M. Ali, and H.Y. Aboul-Enein, Biomed. Chromatogr., 23, 1283 (2009)
  • [19] K.M. Alsante, A. Ando, R. Brown, J. Ensing, T.D. Hatajik, W. Kong, and Y. Tsuda, Adv. Drug Deliv. Rev., 59, 29 (2007)
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  • [22] G.A. Shabir, J. Chromatogr. A, 987, 57 (2003)
Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
bwmeta1.element.baztech-164f0ebe-59b6-40ab-a862-e4e63c9a0e4a
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