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Abstrakty
A simple, selective, precise, and stability-indicating high-performance thin layer chromatographic (HPTLC) method has been established and validated for the analysis of idebenone in bulk drug and formulations. The compounds were analyzed on aluminum-backed silica gel 60 F254 plates with petroleum ether-methanol (4:1, υ/υ) as mobile phase. Densitometric analysis of idebenone was performed at 282 nm. Regression analysis data for the calibration plots were indicative of good linear relationship between response and concentration over the range of 200–600 ng per spot. The correlation coefficient (r2) was 0.989 ± 0.002. The values of slope and intercept of the calibration plots were 2.386 ± 0.0435 and 577.733 ± 19.545, respectively. The method was validated for precision, accuracy, robustness, and ruggedness. The limits of detection and quantification were 14.642 and 44.369 ng, respectively. Idebenone was subjected to acid, base, peroxide, and sunlight degradation. In stability tests, the drug was susceptible to acid and basic hydrolysis, oxidation, and photodegradation.
Słowa kluczowe
Czasopismo
Rocznik
Tom
Strony
281--294
Opis fizyczny
Bibliogr. 14 poz., rys., tab.
Twórcy
autor
- Maulana Azad Education Trust Department of Pharmaceutics, Y.B. Chavan College of Pharmacy Dr. Rafiq Zakaria Marg Aurangabad Maharashtra 431001 India
autor
- Maulana Azad Education Trust Department of Pharmaceutics, Y.B. Chavan College of Pharmacy Dr. Rafiq Zakaria Marg Aurangabad Maharashtra 431001 India
autor
- Maulana Azad Education Trust Department of Pharmaceutics, Y.B. Chavan College of Pharmacy Dr. Rafiq Zakaria Marg Aurangabad Maharashtra 431001 India
autor
- Maulana Azad Education Trust Department of Pharmaceutics, Y.B. Chavan College of Pharmacy Dr. Rafiq Zakaria Marg Aurangabad Maharashtra 431001 India
autor
- University Department of Chemical Technology Dr. BAMU Aurangabad Maharashtra 431134 India
autor
- ash Institute of Pharmacy South City, Bajaj Nagar P.O. Box 968 Waluj, Aurangabad Maharashtra 431134 India
autor
- ash Institute of Pharmacy South City, Bajaj Nagar P.O. Box 968 Waluj, Aurangabad Maharashtra 431134 India
Bibliografia
- [1] ICH, Stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization, IFPMA, Geneva, 2003
- [2] A. Nagaoka, in: A. Scriabine (ed), New Cardiovascular Drugs (Idebenone), Raven Press, New York, 1987, pp. 217–235
- [3] M.F. Wempe, J.W. Lightner, E.L. Zoeller, and P.J. Rice. J. Cos. Dermat., 8, 63–73 (2009)
- [4] H.J. Kim, K.A. Yoon, M. Hahn, E.S. Park, and S.C. Chi. Drug Dev. Ind. Pharm., 26, 523–529 (2000)
- [5] H. Wakabayashi, M. Nakajima, S. Yamato, and K. Shimada. J. Chromatogr., 573, 154–157 (1992)
- [6] M. Francis, R.T. Sane, A. Khatri, and A.R. Pathak. Indian Drugs, 38, 642–645 (2001)
- [7] G.Y. Swamy, K. Ravikumar, and L.K. Wadhwa. Acta. Cryst., 61, 3608–3610 (2005)
- [8] P.D. Sethi, High Performance Thin Layer Chromatography (Quantitative Analysis of Pharmaceutical Formulations), CBS Publishers, New Delhi, 1996, 56–63
- [9] M. Bakshi and S. Singh. J. Pharm. Biomed. Anal., 28, 1011–1040 (2002)
- [10] S. Singh and M. Bakshi. Pharm. Tech., 24, 1–14 (2000)
- [11] ICH, Guidance on Analytical Method Validation, in: Proceedings of the International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September 2002.
- [12] ICH, Q2A Validation of Analytical Procedure, in: Methodology, International Conference on Harmonization, Geneva, October 1994
- [13] ICH, Q2B Validation of Analytical Procedure, in: Methodology, International Conference on Harmonization, Geneva, March 1996
- [14] A.A. Rathi, D.L. Dhamecha, S. Maria, and M.H.G. Dehghan. AJRC, 2, 168–170 (2009)
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-30ec1477-0824-4394-aa96-2e688acb2706