title: Development of an HPLC method for the analysis of Apomine in a topical cream formulation.
abstract: A stability indicating, reversed-phase high performance liquid chromatographic method was developed for the quantification of Apomine, tetraisopropyl 2-(3,5-di-tert-butyl-4-hydroxyphenyl)-ethyl-1, 1-bisphosphonate, in a topical cream formulation. Analysis of Apomine in the cream formulation was performed through a dilution of the cream base with tetrahydrofuran. This allowed the current method to bypass extraction and/or centrifugation for direct injection and analysis. Separation was achieved using an Alltima C18 5 microm, 150 mm x 2.1 mm column and employed a gradient procedure, beginning with acetonitrile-water (65:35, v/v), at 0.6 mL/min for 9 min, followed by a rinse with isopropyl alcohol for 9 min. The complete gradient method has been optimized to separate Apomine from the nonpolar cream components, wash and equilibrate the column in a 30-min assay. This report demonstrates that this method is effective for quantification of Apomine in a cream formulation.
authors.affiliation: College of Pharmacy, University of Arizona, 1703 E. Mabel St., Tucson, AZ 85721, USA. kuehl@pharmacy.arizona.edu
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Kuehl
authors.forename: B Steven
authors.initials: BS
authors.lastname: Angersbach
authors.forename: Steven P
authors.initials: SP
authors.lastname: Stratton
authors.forename: Paul B
authors.initials: PB
authors.lastname: Myrdal
mesh_terms: D000287:Administration, Topical; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004164:Diphosphonates / Q000008:administration & dosage / Q000032:analysis*; D009824:Ointments; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000970:Antineoplastic Agents; D004164:Diphosphonates; D009824:Ointments; C407151:apomine