Evaluation of the stability of frusemide in intravenous infusions by reversed-phase high-performance liquid chromatography

摘要: Abstract A rapid, flexible method based on ion-pair reversed-phase high-performance liquid chromatography is described for the separation and quantitation of frusemide its principal hydrolysis product, saluamine, in presence potential contaminants, photolytic products other degradants. The stability-indicating has been shown to be applicable determination saluamine injectable forms frusemide. Response was linear both (0−50 jug/ml; r = 0.9999) (0−10 μg/ml; 1.0000). on-column sensitivity assay 1.3 ng 1.1 saluamine. applied intravenous admixtures studies effect heat and/or light stress dosage forms. found sufficiently sensitive monitor low levels degradation absence degradation. When injection transferred a polypropylene syringe slow stored at room temperature unprotected from 24 h, level degradation, as indicated by remained 0.2%, which within 1% compendial limit used an additive Compound Sodium Lactate Injection BP (Hartmann's Solution) or Chloride 0.9% w/v, stable h without protection light. An autoclaved infusion 10 weeks when protected preliminary investigation fall pH 3 units, precipitation number uncharacterized products. impurities were detected Saluamine Chemical Reference Substance.