Determination of Minor Impurities and Diastereomers of 6-[3-[(2-Amino-1-Oxopentyl)Amino]-1-Pyrrolidinyl]-5-Fluoro-3-Oxo-3h-Pyrido[3,2,1-Kl]Phen-Oxazine-2-Carboxylic Acid Hydrochloride by High Performance Liquid Chromatography

Abstract

Diastereomers of the quinobenoxazine antineoplastic drug Abbott-84441.1 and minor impurities were determined using high-performance liquid chromatography. Manufacturing impurities, degradation products, and diastereomers were separated usingreversed-phase system with gradient elution. Detector response was linear for Abbott-84441.1 to approximately 20 γg/mL which represents 4.0% of the drug concentration. The procedure provides quantitation of impurities to approximately the 0.1% level with precision (relative standard deviations) of 7.3% to 31% in typical bulk drug lots.variety of reversed-phase columns were evaluated for the assay method with the optimum resolution achieved using5-μm Alltima C₁₈ packing.