Add time:07/30/2019         Source:sciencedirect.com

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 (C8) 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 (cas 10403-51-7). 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.

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