Determination of minor impurities in temafloxacin hydrochloride by high-performance liquid chromatography |
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Authors: | L Elrod C L Linton B P Shelat C F Wong |
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Institution: | PPD Analytical Research Department, Abbott Laboratories, North Chicago, IL 60064. |
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Abstract: | Minor impurities in the antibacterial agent temafloxacin hydrochloride were determined using high-performance liquid chromatography. Manufacturing impurities and degradation products were separated using a reversed-phase system with gradient elution. Detector response was linear for the individual impurities to approximately 50 micrograms/ml which represents 2.5% of the drug concentration. The procedure provides quantitation of impurities to approximately the 0.05% level with precision (relative standard deviations) of 4.7% to 29% in typical bulk drug lots. A variety of reversed-phase columns were evaluated for the assay method with optimum resolution achieved using a 5-microns Nucleosil C18 packing. |
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