title: A sensitive high-throughput HPLC assay for simultaneous determination of everolimus and clobetasol propionate.
abstract: 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 microg/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.
authors.affiliation: Department of Analytical Sciences, Abbott Vascular, Inc., Santa Clara, CA 95054-2807, USA. kmarika55@hotmail.com
authors.forename: Marika
authors.initials: M
authors.lastname: Kamberi
authors.forename: Katherine
authors.initials: K
authors.lastname: Fu
authors.forename: Jianmin
authors.initials: J
authors.lastname: Lu
authors.forename: G Mike
authors.initials: GM
authors.lastname: Chemaly
authors.forename: Debra
authors.initials: D
authors.lastname: Feder
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002990:Clobetasol / Q000032:analysis* / Q000737:chemistry; D000068338:Everolimus; D015394:Molecular Structure; D015203:Reproducibility of Results; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry
chemical_list: D000068338:Everolimus; D002990:Clobetasol; D020123:Sirolimus