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前言:To develop a direct-detection gentamicin assay that eliminates o-phthalaldehyde, as used in the U.S. Pharmacopeia (USP) monograph1 or other derivatization methods.
Methods: Using UHPLC and a Thermo Scientific Dionex Corona ultra RS Charged Aerosol Detector, an assay is developed to separate the congeners in gentamicin sulfate and gentamicin-sulfate-containing products with a mobile phase comprised of lower ionpairing reagent concentrations as compared to many previously published methods.
结论: Assay of four samples with three different matrices gave results that were equal to the product label claims.