Add time:07/17/2019         Source:sciencedirect.com

Minor impurities in the antibacterial agent TEMAFLOXACIN HYDROCHLORIDE (cas 105784-61-0) 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 μg/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-μm Nucleosil C18 packing.

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