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Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
46, Number 1, January 2008, pp. 23-29
A Sensitive High-Throughput HPLC Assay for Simultaneous
Determination of Everolimus and Clobetasol Propionate
Kamberi Marika, Fu Katherine, Lu Jianmin, Chemaly
G. Mike, and Feder Debra
Department of Analytical Sciences, Abbott Vascular, Inc., Santa
Clara, CA 95054-2807
A novel sensitive high-throughput high-performance
liquid chromatography assay is developed and validated for the
simultaneous determination of everolimus and clobetasol propionate
in pharmaceutical formulations. The chromatographic separation
is achieved on a Zorbax Eclipse XDB-C18 reversed-phase column
using a gradient elution, with solvent A: ammonium acetate (pH
6.8; 0.01 M) and solvent B: acetonitrile. The mean recovery ranges
from 95.1% to 100.0% for clobetasol propionate and from 97.9%
to 103.7% for everolimus. The limit of quantitation for each
analyte is 0.02 µg/mL. The percent relative standard deviations
are less than 3% for intra- and inter-day analyses. The proposed
method can be used for the routine quality control of everolimus
and clobetasol propionate in complex pharmaceutical formulations,
especially the drug-delivery systems with a low total drug-load.
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