Development of an HPLC method for the analysis of Apomine in a topical cream formulation

Philip J. Kuehl, B. Steven Angersbach, Steven P. Stratton, Paul B. Myrdal

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

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 μm, 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.

Original languageEnglish (US)
Pages (from-to)975-980
Number of pages6
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume40
Issue number4
DOIs
StatePublished - Mar 3 2006

Keywords

  • Apomine
  • Cream formulation
  • RP-HPLC method
  • Topical formulation

ASJC Scopus subject areas

  • Analytical Chemistry
  • Pharmaceutical Science
  • Drug Discovery
  • Spectroscopy
  • Clinical Biochemistry

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