High-performance liquid chromatographic determination of suprofen in drug substance and capsules.

A rapid, simple, stability-indicating assay procedure for suprofen, a new analgesic agent, in suprofen drug substance and in capsules was developed using high-performance liquid chromatography. Suprofen was extracted from the sample matrix with methanol and diluted with internal standard solution, and an aliquot was chromatographed on a reversed-phased column using acetonitrile-pH 3.0 buffer solution as the mobile phase. The selectivity of te chromatographic system for intact suprofen was demonstrated by resolving suprofen from synthetic intermediates, potential impurities, and reaction products resulting from accelerated stress conditions. The method is linear, quantitative, and reproducible. Either peak height or peak area ratios can be used for quantitation.