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  • 1 Faculty of Pharmacy, Beni-Suef University, AlshaheedShehata Ahmad Hegazy St., 62514, Beni-Suef, Egypt
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A validated, sensitive, and highly selective stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been adopted for the quantitative determination of pyridostigmine bromide in the presence of its alkaline-induced degradation product and in pharmaceutical formulations. 3-hydroxy-N-methyl pyridinium bromide (3-OH NMP) is the metabolite, impurity, and alkaline-induced degradation product of pyridostigmine bromide (PB). Pyridostigmine bromide and its alkaline-induced degradation product were separated on silica gel HPTLC F254 plates using methanol–ethyl acetate–triethyl amine–glacial acetic acid (9:1:0.5:0.05 by volume) as the developing system followed by scanning of the separated bands at 270 nm over a concentration range of 2–10 μg band−1 with mean percentage recoveries of 99.84% (SD 1.384). The proposed method was successfully applied to the analysis of pyridostigmine bromide both in bulk powder and in pharmaceutical formulation without interference from other dosage form additives. The results obtained by the proposed method were statistically compared with those obtained by the reported HPLC method with no significant difference regarding both accuracy and precision, indicating the ability of the proposed method to be reliable and suitable for routine analysis of a drug product.

  • [1]

    The British Pharmacopoeia, Her Majesty’s Stationary Office, London, 2007.

  • [2]

    The United States Pharmacopeia, 32nd edn., National Formulary 27, United States Pharmacopeia Convention Inc., Rockville, MD, 2009.

  • [3]

    Merck Index, 13th edn., Merck Research Laboratories, Division of Merck & Co., Inc., Whitehouse Station, NJ, 2001.

  • [4]

    Martindale, Extra Pharmacopoeia, 34th edn., The Complete Drug References, The Pharmaceutical Press, London, 2005.

  • [5]

    U. Breyer-Pfaff , U. Maier, A.M. Brinkmann, F. Schumm, Clin. Pharmacol. Ther. 37 (1985) 495501.

  • [6]

    R.M. Sapolsky , Nature 393 (1998) 308309.

  • [7]

    M. Xu , Q. Tan, S. Liu, L. Zhang, J. Zhang, Zhungguo Yao Fang 22 (2011) 743745.

  • [8]

    G.J. Yakatan , J-Y. Tien, J. Chromatogr. 164 (1979) 399403.

  • [9]

    D.W. Blick , M.R. Murphy, G.C. Brown, M.G. Yochmowitz, J.W. Fanton, S.L. Hartgraves, Toxicol. Appl. Pharmacol. 126 (1994)311318.

  • [10]

    S.R. Needham , B. Ye, J.R. Smith, W.D. Korte, J. Chromatogr. B 796 (2003) 347354.

  • [11]

    S. Cherstniakova , G. Garcia, J. Strong, N. Helbling, D. Bi, M. Roy, L.R. Cantilena, Clin. Pharmacol. Ther. 73 (2003) 27.

  • [12]

    K. Chan , N.E. Williams, J.D. Baty, T.N. Calvey, J. Chromatogr. 120 (1976) 349358.

  • [13]

    S.L. Cohan , J.L. Pohlmann, J. Mikszewski, D.S. O’Doherty, Neurology 26 (1976) 536539.

  • [14]

    S.C. Davison , N. Hyman, R.A. Prentis, A. Dehghan, K. Chan, Methods Find. Exp. Clin. Pharmacol. 2 (1980) 7782.

  • [15]

    P.S. Sorensen , H. Flachs, M.L. Friis, E.F. Hvidberg, O.B. Paulson, Neurology 34 (1984) 10201024.

  • [16]

    K.D. Altria , J. Bestford, J. Capill. Electrophor. 3 (1996) 1323.

  • [17]

    M. Hadley , M. Gilges, J. Senior, A. Shah, P. Camilleri, J. Chromatogr. B 745 (2000) 177188.

  • [18]

    J. Havel , J. Patocka, G. Bocaz, J. Capill. Electrophor. Microchip Technol. 7 (2002) 107112.

  • [19]

    P. Kornfeld , A.J. Samuels, R.L. Wolf, K.E. Osserman, Neurology (Minneap.) 20 (1970) 634641.

  • [20]

    H.E. Barber , G.R. Bourne, T.N. Calvey, K.T. Muir, Br. J. Pharmacol. 55 (1975) 335341.

  • [21]

    R.D.N. Birtley , J.B. Roberts, B.H. Thomas, A. Wilson, Br. J. Pharmacol. Chemother. 26 (1966) 393402.

  • [22]

    A.W. Abu-Qare , M.B. Abou-Donia, J. Pharm. Biomed. Anal. 26 (2001) 281289.

  • [23]

    M.G. De Ruyter, R. Cronnelly, J. Chromatogr. 183 (1980) 193201.

  • [24]

    A.W. Abu-Qare , M.B. Abou-Donia, J. Chromatogr. B 754 (2001) 503509.

  • [25]

    B. Zhao , S. Moochala, J. Lu, D. Tan, M. Lai, J. Pharm. Pharm. Sci. 9 (2006) 7181.

  • [26]

    ICH, Q2 (R1), Validation of Analytical Procedures, Proceedings of the International Conference on Harmonization, Geneva, 2005.

  • [27]

    US FDA Guidance, Analytical Procedures and Methods Validation, Food and Drug Administration, Rockville, MD, 2000.

  • [28]

    J.C, Miller , J.N. Miller, Statistical and Chemometrics Methods for Analytical Chemistry, 4th edn., Pearson Education Ltd., London, 2000, p. 98.

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Journal of Planar Chromatography - Modern TLC
Language English
Size A4
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