Quantitative Determination of Oxaprozin and Several of Its Related Compounds by High-Performance Reversed-Phase Liquid Chromatography

Abstract

Abstract An accurate, sensitive, and selective high-performance liquid chromatographic method for the quantitative determination and the separation of oxaprozin from several of its related compounds (including some precursors) has been developed. Reversed-phase ion-pair chromatography, with 1-decanesulfonic acid sodium salt as the ion pairing agent, was used. A μ Bondapak C18 column with a mobile phase consisting of 0.01 M KH2PO4, methanol, and acetonitrile (2:1:1), pH 4.2, was used at a flow rate of 1 mL/min. Oxaprozin and its related compounds were monitored at 254nm. The method is rapid because no sample extraction is involved. Precision and ruggedness (relative standard deviation) on oxaprozin and several of its related compounds were below 1.0%. Detection limits ranged from 0.05 μg/mL to 0.08 μg/mL depending on the compound. The method is stability-indicating, and has applications in bulk pharmaceutical manufacturing.