Determination of minor impurities in temafloxacin hydrochloride by high-performance liquid chromatography.
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.
Elrod
L
L
PPD Analytical Research Department, Abbott Laboratories, North Chicago, IL 60064.
Linton
C L
CL
Shelat
B P
BP
Wong
C F
CF
D042462:4-Quinolones; D000890:Anti-Infective Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D024841:Fluoroquinolones; D015363:Quinolones
D042462:4-Quinolones; D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D015363:Quinolones; C054745:temafloxacin