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A validated stability-indicating method for simultaneous analysis of mevastatin and pravastatin in fermentation broth during bioconversion by Actinomadura macra

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A simple, accurate, selective, precise, economical, and stability-indicating high-performance thin-layer chromatographic method for simultaneous analysis of mevastatin and pravastatin in fermentation broth has been established and validated. Compounds were separated on aluminium foil TLC plates precoated with silica gel 60F254; the mobile phase was toluene-ethyl acetate-formic acid 3:2:1 (v/v), which gave compact bands of mevastatin and pravastatin (RF 0.48 ± 0.02 and 0.31 ± 0.02, respectively). Detection at 237 nm resulted in r = 0.992 and 0.995 for mevastatin and r = 0.995 and 0.994 for pravastatin, for peak height and peak area, respectively. The limits of detection and quantification for mevastatin were 20.1 and 60.8 ng per band, and for pravastatin 19.2 and 58.3 ng per band, respectively. The method enabled effective quantification of mevastatin and pravastatin in the fermentation broth of Actinomadura macra and can therefore be used as a stability-indicating method for routine analysis of these compounds during bioconversion.
Rocznik
Strony
121--131
Opis fizyczny
Bibliogr. 18 poz., rys., tab.
Twórcy
autor
  • Faculty of Pharmacy, Jamia Hamdard Pharmaceutical Biotechnology Laboratory New Delhi India 110062
autor
  • Faculty of Pharmacy, Jamia Hamdard Pharmaceutical Biotechnology Laboratory New Delhi India 110062
autor
  • Faculty of Pharmacy, Jamia Hamdard Pharmaceutical Biotechnology Laboratory New Delhi India 110062
Bibliografia
  • [1] M. Arai, N. Serizawa, A. Terahara, Y. Tsujita, M. Tanaka, H. Masuda, and S. Ishikawa, Sankyo Kenkyusyo Nenpo, 40, 1–38 (1988)
  • [2] N. Serizawa and T. Matsuoka, Biochim. Biophys. Acta, 1084, 35–40 (1991)
  • [3] Y. Tsujita, M. Kuroda, Y. Shimada, K. Tanzawa, M. Arai, I. Kaneko, M. Tanaka, H. Masuda, C. Tarumi, and Y. Watanabe, Biochim. Biophys. Acta, 877, 50–60 (1986)
  • [4] R. Chakravarti and V. Sahai, Biotechnol. Lett., 24, 527–530 (2002)
  • [5] C.H. Chen, H.Y. Hu, Y.C. Cho, and W.H. Hsu, Curr. Microbiol., 53, 108–112 (2006)
  • [6] M. Manzoni, M. Rollini, S. Bergomi, and V. Cavazzoni, Biotechnol. Tech., 12, 529–532 (1998)
  • [7] R. Grahek, D. Milivojevic, A. Bastarda, and M. Kracum, J. Chromatogr. A, 918, 319–324 (2001)
  • [8] G. Jiang, R. Chen, and C. Loran, Application Note 402, Thermo Fisher Scientific, San Jose, CA, 2007
  • [9] A. Puri, A. Ahmad, and B.P. Panda, Biomed. Chromatogr., 1382, DOI10.1002/bmc (2009)
  • [10] J. Ali, N. Akhtar, Y. Sultana, S. Baboota, and S. Ahmad, Acta Chromatogr., 2, 277–282 (2008)
  • [11] H. Wagner and S. Bladt, Plant Drug Analysis: A Thin Layer Chromatography Atlas. Springer, New York, 1988, pp. 359
  • [12] S. Ahmad, M. Rizwan, R. Parveen, M. Mujeeb, and M. Aquil, Chromatographia, 67, 441–447 (2008)
  • [13] S. Mennickent, R. Fierro, M. Vega, M. Diego, C.G. Godoy, J. Sep. Sci., 32, 1454–1458 (2009)
  • [14] ICH Draft guidelines on validation of analytical procedures: definition and terminology, federal register, IFPMA, Switzerland, 1995
  • [15] R. Chakravarti and V. Sahai, Proc. Biochem., 38, 481–486 (2002)
  • [16] ICH Stability testing of new drug substances and products (Q1AR2), in: Proceedings of the international conference on harmonization, IFPMA, Geneva, 2003
  • [17] ICH Text on Validation of Analytical Procedures, Harmonised Tripartite Guideline prepared within the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, ICH-Q2A, Geneva, 1994
  • [18] ICH Validation of Analytical Procedures: Methodology, Harmonised Tripartite Guideline prepared within the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, ICH-Q2B, Geneva, 1996
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-a0211093-6437-4cbb-8ccb-55d737bf8453
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