Determination of Ketoconazole in tablets by using three different methods

  • Biljana Gjorgjeska University “Goce Delcev”, Stip
Keywords: Operation, control, regulation of instruments

Abstract

Ketoconazole has been widely used as an antifungal drug  that is formulated as tablets, cream and over­the­counter ketoconazole shampoo. The aim of this research was to study and to standardize an ultraviolet spectrophotometric (UVS) method, potentiometric  and a high  performance  liquid  chromatographic  (HPLC) method  for  the determination  of ketoconazole in commercially available Oromycosal® tablets. These three methods were compared and discussed with respect to  their  sensitivity,  selectivity  and ready­applicability  in  routine  analytical  work.   Absorption  spectra and spectrophotometric determinations were carried out on the UVS spectrophotometer. Investigated concentrations were in range from  0.003 to  0.02mg?dm­3. The absorbance was measured at 224  nm.  In potentiometric  titrations  glass  and saturated (KCl) calomel electrode were used. HPLC analyses of ketoconazole were carried in the presence of econazole as internal standard. It can be concluded that the described methods are simple, fast and reliable for determination of ketoconazole in pharmaceutical preparations. The preparation of the samples is easy, the excipients do not  interfere in the methods, so they can be used in routine quality control analysis.

References

Arranz P, Arranz A, Moreda JM, Cid A, Arranz JF. Stripping voltammetric and polarographic techniques for the determination of anti­fungal ketoconazole on the mercury electrode, (2003) J. Pharm.Biom. Anal., New York, 33, 589­596

El­Shabouri SR, Emara KM, Kashaba PY, Mohamed AM. Charge­transfer complexation for spectrophotometric assay of certain Imidazole antifungal drugs (1998) Anal. Lett, New York, 31, 1367­1385

European Pharmacopoeia (2008) 6th Ed., Ketoconazole 01/2008:0921 corrected 6.0, European Pharmacopoeia

Commission, 2216­2218

Heyden YV, Nguyet ANM, Detaevernier MR, Massart DL and Vercammen JP. Simultaneous determination of ketoconazole and formaldehyde in a shampoo: liquid chromatography method development and validation, (2002) J. Chromatogr. A 958,

­201

Staub I, Bergold AM. Determination of Ketoconazole in Shampoo by High Performance Liquid Chromatography (2004) Acta Farm. Bonaerense 23 (3), 387­390

The United States Pharmacopoeia 32th NF 27 (2009), Ketoconazole, Ed. Rockwille: United States Pharmacopeial

Convention, 2737­2738

Vander Heyde Y, Nguyen Minh Nguyet A, Detaevenier M R, Massart D L, Plaizier­Vercammen J. Simultaneous determination of ketoconazole and formaldehyde in a shampoo: liquid chromatography method development and validation (2002) Journal of Chromatography A 958 (1­2), 191­201

Published
2012-10-01
Section
Articles