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Microbiological and HPLC analysis of miconazole in skin, serum and phase-solubility studies
P Puranajoti1, R Kasina, S Tenjarla
1Department of Pharmaceutical Sciences, Mercer University, 3001 Mercer University Drive, Atlanta, GA 30341, USA.
Objective:
To develop stability-indicating assays for miconazole.
Methods:
A reversed phase high-performance liquid chromatographic assay and a bioassay were developed.
Results:
The HPLC and the bioassay were linear in the range of 0.5-100 and 0.64-1.56 microg/ml, respectively. The sensitivity of HPLC and bioassay were 0.5 and 0. 64 microg/ml, respectively. The bioassay was less cumbersome and much faster than the HPLC assay by obviating the need for extraction from serum. Miconazole content in the phase-solubility studies and in the serum samples was comparatively evaluated by both assay methods. There was good correlation between the two methods (r2 > 0. 99). The drug extraction efficiency from the serum and the skin were 97.7 and 90.2%, respectively. Where necessary, the bioassay can be an alternative choice for the HPLC analysis. The within and between day variations of the HPLC assay were 3.6 and 4.9%, respectively.