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.
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Golich et al. (1994) studied this question.
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