European Journal of Chemistry 2015, 6(3), 350-356. doi:10.5155/eurjchem.6.3.350-356.1283

Development and validation of three spectrophotometric methods for determination of pyridostigmine bromide in the presence of its alkaline-induced degradation product


Eglal Abdelhamid Abdelaleem (1) , Ibrahim Ahmed Naguib (2) , Fatma Fared Abdallah (3,*) , Nouruddin Wageih Ali (4)

(1) Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, 62514, Beni-Suef, Egypt
(2) Pharmaceutical Chemistry Department, Faculty of Pharmacy, University of Tabuk, 71491, Tabuk, Kingdom of Saudi Arabia
(3) Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, 62514, Beni-Suef, Egypt
(4) Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, 62514, Beni-Suef, Egypt
(*) Corresponding Author

Received: 11 Jun 2015, Accepted: 15 Jul 2015, Published: 30 Sep 2015

Abstract


Three simple, accurate and validated spectrophotometric methods were developed for the determination of pyridostigmine bromide (PB) in presence of its alkaline-induced degradation product, 3-hydoxy-N-methylpyridinium bromide (3-OH NMP) in powder form and in pharmaceutical formulations. Method A, is first derivative method (1D), which is based on measuring the peak amplitude of the first derivative spectra (1D) of PB at 260 nm. Method B, is first derivative of ratio spectra (1DD) which allows the determination of PB at 267.4 nm using (50 µg/mL) of 3-OH NMP as a suitable devisor. Finally, method C depends on mean centering of ratio spectra (MCR) of PB with different concentrations, which were recorded over 200-400 nm and divided by the spectrum of 20 µg/mL of 3-OH NMP as a devisor. The obtained ratio spectra were mean centered and the concentrations of PB were then determined from the calibration graphs obtained by measuring the amplitudes at 338 nm. The proposed methods were successfully applied for assay of PB both in pure form and in pharmaceutical formulations. The proposed methods were validated in compliance with International Conference on Harmonization (ICH) guidelines. The results obtained by the developed methods were statistically compared to those obtained by the reported HPLC method using F- and student's t-tests showing no significant difference regarding both accuracy and precision.


Keywords


First derivative method; Pyridostigmine bromide; Spectrophotometric method; First derivative ration spectra; Mean centering of ratio spectra; 3-Hydoxy-N-methylpyridinium bromide

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DOI: 10.5155/eurjchem.6.3.350-356.1283

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References

[1]. The British Pharmacopoeia, Her Majesty's, The Stationary Office, London, 2007.

[2]. The United States Pharmacopeia, 32 Ed., National Formulary 27, United States Pharmacopeial convention INC, USA, 2009.

[3]. Breyer-Pfaff, U.; Maier, U.; Brinkmann, A. M.; Schumm, F. Clin. Pharmacol. Ther. 1985, 37, 495-501.
http://dx.doi.org/10.1038/clpt.1985.78

[4]. Sweetman S. C., Extra Pharmacopoeia 34th Edition, The Complete Drug References, The pharmaceutical Press, London, UK, 2005.

[5]. O'Neil, M. J. The merck index: An encyclopedia of Chemicals, Drugs and Biologicals, 13th Edition, Merck, Rahway, NJ, 2001.

[6]. Sapolsky, R. M. Nature 1998, 393, 308-309.
http://dx.doi.org/10.1038/30606

[7]. Xu, M.; Tan, Q.; Liu, S.; Zhang, L.; Zhang, J. J. Zhangguo Yao Fang 2011, 22, 743-745.

[8]. Yakatan, G. J.; Tien, J. Y. J. Chromatogr. 1979, 164, 399-403.
http://dx.doi.org/10.1016/S0378-4347(00)81242-6

[9]. Blick, D. W.; Murphy, M. R.; Brown, G. C.; Yochmowitz, M. G.; Fanton, J. W.; Hartgraves, S. L. Toxicol. Appl. Pharmacol. 1994, 126, 311-318.
http://dx.doi.org/10.1006/taap.1994.1121

[10]. Needham, S. R.; Ye, B.; Smith, J. R.; Korte, W. D. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2003, 796, 347-354.
http://dx.doi.org/10.1016/j.jchromb.2003.08.021

[11]. Cherstniakova, S.; Garcia, G.; Strong, J.; Helbling, N.; Bi, D.; Roy, M.; Cantilena, L. R. Clin. Pharmacol. Ther. 2003, 73, 27-27.
http://dx.doi.org/10.1016/S0009-9236(03)90453-X

[12]. Chan, K.; Williams, N. E.; Baty, J. D.; Calvey, T. N. J. Chromatogr. 1976, 120, 349-358.
http://dx.doi.org/10.1016/S0021-9673(76)80012-X

[13]. Cohan, S. L.; Pohlmann, J. L.; Mikszewski, J.; O'Doherty, D. S. Neurology 1976, 26, 536-539.
http://dx.doi.org/10.1212/WNL.26.6.536

[14]. Davison, S. C.; Hyman, N.; Prentis, R. A.; Dehghan, A.; Chan, K. Methods Find Exp Clin Pharmacol. 1980, 2, 77-82.

[15]. Sorensen, P. S.; Flachs, H.; Friis, M. L.; Hvidberg, E. F.; Paulson, O. B. Neurology 1984, 34, 1020-1024.
http://dx.doi.org/10.1212/WNL.34.8.1020

[16]. Altria, K. D.; Bestford, J. J. Cap. Elec. 1996, 3, 13-23.

[17]. Hadley, M.; Gilges, M.; Senior, J.; Shah, A.; Camilleri, P. J. Chromatogr. B. 2000, 745, 177-188.
http://dx.doi.org/10.1016/S0378-4347(00)00153-5

[18]. Havel, J.; Patocka, J.; Bocaz, G. J. Cap. Elec. Microchip Tech. 2002, 7, 107-112.

[19]. Kornfeld, P.; Samuels, A. J.; Wolf, R. L.; Osserman, K. E. Neurology 1970, 20, 634-641.
http://dx.doi.org/10.1212/WNL.20.7.634

[20]. Birtley, R. D. N.; Roberts, J. B.; Thomas, B. H.; Wilson, A. Br. J. Pharmacol. Chemother. 1966, 26, 393-402.
http://dx.doi.org/10.1111/j.1476-5381.1966.tb01919.x

[21]. Barber, H. E.; Bourne, G. R.; Calvey, T. N.; Muir, K. T. Br. J. Pharmacol. 1975, 55, 335-341.
http://dx.doi.org/10.1111/j.1476-5381.1975.tb06936.x

[22]. Abu-Qare, A. W.; Abou-Donia, M. B. J. Pharm. Biomed. Anal. 2001, 26, 281-289.
http://dx.doi.org/10.1016/S0731-7085(01)00403-4

[23]. De Ruyter, M. G.; Cronnelly, R. J. Chromatogr. 1980, 183, 193-201.
http://dx.doi.org/10.1016/S0378-4347(00)81693-X

[24]. Abu-Qare, A. W.; Abou-Donia M. B. J. Chromatogr. B. 2001, 754, 503-509.
http://dx.doi.org/10.1016/S0378-4347(01)00040-8

[25]. Agarwal, S.; Gowda, K. V.; Mandal, U.; Ghosh, D.; Bose, A.; Sarkar, A. K.; Chattaraj, T. K. J. Liq. Chromatogr. Rel. Tech. 2007, 30(17), 2605-2615. ‏
http://dx.doi.org/10.1080/10826070701540605

[26]. Zhao, B.; Moochala, S.; Lu, J.; Tan, D.; Lai, M. J. Pharm. Pharm. Sci. 2006, 9, 71-81.

[27]. Naguib, I. A.; Abdelrahman, M. M.; El Ghobashy, M. R.; Ali, N. A. J. Chromatogr. Sci. 2015, 53(8), 1395-1399.
http://dx.doi.org/10.1093/chromsci/bmv015

[28]. Ali, N. W.; ZaaZaa, H. A.; Abdelkawy, M.; Magdy, M. A. Biomed. Chromatogr. 2012, 26(10), 1143-1149. ‏
http://dx.doi.org/10.1002/bmc.2669

[29]. Naguib, I. A.; Abdelaleem, E. A.; Zaazaa, H. E. and Abd ElWahab, H. E. Eur. J. Chem. 2014, 5(2), 219-226.
http://dx.doi.org/10.5155/eurjchem.5.2.219-226.966

[30]. Abdelaleem, E. A.; Abdelwahab, N. S. Chem. Cent. J. 2012, 6(1), 27-27.‏
http://dx.doi.org/10.1186/1752-153X-6-27

[31]. Afkhami, A.; Bahram, M. Anal. Chim. Acta 2004, 526, 211-218.
http://dx.doi.org/10.1016/j.aca.2004.09.064

[32]. Afkhami, A.; Bahram, M. Talanta 2005, 66, 712-720.
http://dx.doi.org/10.1016/j.talanta.2004.12.004

[33]. Afkhami, A.; Bahram, M. Talanta 2006, 68, 1148-1155.
http://dx.doi.org/10.1016/j.talanta.2005.07.017

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


How to cite


Abdelaleem, E.; Naguib, I.; Abdallah, F.; Ali, N. Eur. J. Chem. 2015, 6(3), 350-356. doi:10.5155/eurjchem.6.3.350-356.1283
Abdelaleem, E.; Naguib, I.; Abdallah, F.; Ali, N. Development and validation of three spectrophotometric methods for determination of pyridostigmine bromide in the presence of its alkaline-induced degradation product. Eur. J. Chem. 2015, 6(3), 350-356. doi:10.5155/eurjchem.6.3.350-356.1283
Abdelaleem, E., Naguib, I., Abdallah, F., & Ali, N. (2015). Development and validation of three spectrophotometric methods for determination of pyridostigmine bromide in the presence of its alkaline-induced degradation product. European Journal of Chemistry, 6(3), 350-356. doi:10.5155/eurjchem.6.3.350-356.1283
Abdelaleem, Eglal, Ibrahim Ahmed Naguib, Fatma Fared Abdallah, & Nouruddin Wageih Ali. "Development and validation of three spectrophotometric methods for determination of pyridostigmine bromide in the presence of its alkaline-induced degradation product." European Journal of Chemistry [Online], 6.3 (2015): 350-356. Web. 22 Sep. 2019
Abdelaleem, Eglal, Naguib, Ibrahim, Abdallah, Fatma, AND Ali, Nouruddin. "Development and validation of three spectrophotometric methods for determination of pyridostigmine bromide in the presence of its alkaline-induced degradation product" European Journal of Chemistry [Online], Volume 6 Number 3 (30 September 2015)

DOI Link: https://doi.org/10.5155/eurjchem.6.3.350-356.1283

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