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Abstract
A reversed phase linear gradient liquid chromatographic method was developed for the separation and quantitative determination of the seven known process related impurities and one degraded product of oxaprozin in the bulk drug material. An Inertsil-ODS 3V (150×4.6 mm), 5 μm column was operated with a phosphate buffer–acetonitrile gradient. Detection was carried out on a UV detector at 254 nm. This method has been proved to be accurate and sensitive. The limits of detection (LOD) and limits of quantification (LOQ) of impurities were in the order of 5–60 ng and 16–200 ng, respectively. In addition to its ruggedness and robustness, this method offers identification of all eight impurities in a single run.
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