Abstract
The acetonide of 6α-fluoro-16α-hydroxyhydrocortisone, prepared from C14-labeled acetone, was formulated as a cream. Initial assays were made by a conventional tetrazolium method and also by a thin-layer chromatographic separation and subsequent scintillation measurement of the C14-labeled steroid. The cream samples were aged under accelerated conditions, and subsequent assays by the two methods were compared to the initial results. Small assay interferences caused by the aging of the formulation were demonstrated on the tetrazolium method. The techniques used illustrated advantages of the thin-layer chromatographic scintillation method for the early evaluation of a proposed stability method for a cream formulation. The acetonide of 6α-fluoro-16α-hydroxyhydrocortisone, prepared from C14-labeled acetone, was formulated as a cream. Initial assays were made by a conventional tetrazolium method and also by a thin-layer chromatographic separation and subsequent scintillation measurement of the C14-labeled steroid. The cream samples were aged under accelerated conditions, and subsequent assays by the two methods were compared to the initial results. Small assay interferences caused by the aging of the formulation were demonstrated on the tetrazolium method. The techniques used illustrated advantages of the thin-layer chromatographic scintillation method for the early evaluation of a proposed stability method for a cream formulation.
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