Stability indicating assay for fetindomide (NSC 373965), a potential prodrug of mitindomide (NSC 284356), employing high-performance liquid chromatography.
A stability indicating assay for fetindomide using reversed-phase high-performance liquid chromatography (HPLC) has been developed. The chromatography was performed on a MOS Hypersil (C(8)) column and was optimized by investigating the effects of methanol (7.5-20%), acetonitrile (5-7%), tetrabutylammonium hydrogen-sulphate (TBA, 0-90 mM) and acetate buffer (pH 3.5, 60-100 mM) on the retention of fetindomide and mitindomide. The optimum mobile phase was 5% acetonitrile in an aqueous solution containing 100 mM acetate buffer (pH 3.5) and 40 mM TBA. Complete resolution of fetindomide, and its degradation products, phenylalanine, the two isomers of N-phenylalanyloxymethylmitindomide and mitindomide was achieved within 10 min at a flow rate of 2 ml/min. The method is linear, accurate and precise for the determination of fetindomide and mitindomide and was applied to study the stability of fetindomide in various aqueous media.
Umprayn
K
K
Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66045, USA.
Stella
V J
VJ
Riley
C M
CM