Microbiological and HPLC analysis of miconazole in skin, serum and phase-solubility studies.
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.
Puranajoti
P
P
Department of Pharmaceutical Sciences, Mercer University, 3001 Mercer University Drive, Atlanta, GA 30341, USA.
Kasina
R
R
Tenjarla
S
S
D000818:Animals; D001681:Biological Assay / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D003505:Cyclodextrins / Q000032:analysis; D004355:Drug Stability; D051379:Mice; D008812:Mice, Hairless; D008825:Miconazole / Q000097:blood / Q000493:pharmacokinetics*; D008828:Microbiological Techniques; D010539:Permeability; D012441:Saccharomyces cerevisiae / Q000187:drug effects*; D012680:Sensitivity and Specificity; D012867:Skin / Q000378:metabolism*; D012995:Solubility
D003505:Cyclodextrins; D008825:Miconazole