A high-performance liquid chromatographic (HPLC) method for analyzing mebendazole

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A rapid and sensitive high-performance liquid chromatographic (HPLC) method is described for characterizing and quantifying mebendazole in bulk and in Pharmaceutical formulations. The method was a simple and straightforward procedure involving sample dissolution (in formic acid), dilution of the supematant to obtain a final concentration in the range 1 5-20μg/ml, and injection of sample solution (20μl volume) onto the column. The chromatographic separation was achieved on an octa-decyl reversed-phase column with UVdetection at 247nm. Quantitation was accomplished using an internal standard of albendazole reference standard; peak area ratios being determined with an integrating computer. The mode of operation was isocratic and was performed at ambient temperature requiring only 6 minutes of chromatography time. The standard curves obtained were linear over the concentration range O.5-3Oμg/ml. The mean percentage content of active constituent calculated from assay of a total of eight commercial preparations of mebendazole was 97.97% with a relative standard deviation of 1.52 compared to a relative standard deviation of 2.69 for the pharmacopoeial spectrophotometric method, (USP). The method was used to determine two commercial brands of albendazole at 237nm detection wavelength, using USP mebendazole reference standard as internal standard. The results obtained showed high reproducibility and an excellent measure of accuracy. Conditions of worm infestation are widespread and prevalent health hazards for which chemotherapeutic agents like mebendazole and albendazole are effectively used to combat. The method developed and described in the text presents the needed analytical technique for evaluating the integrity, and ascertaining the level of potency of such anthelmintic products in commercial circulation.
A thesis submitted to the Board of Postgraduate Studies, Kwame Nkrumah University of Science and Technology, Kumasi, in partial fulfilment of the requirement for the award of the Degree of Master of Science in Pharmaceutical Chemistry, 1998