Abstract
Abstract This report describes a reverse-phase HPLC assay for the antiulcer drug, enprostil, formulated as a 0.3 mM solution (in propylene carbonate) filled into soft elastic gelatin capsules. The method uses: a 5 μm C18 column, a ternary (THF-methanol-phosphate buffer) mobile phase and 220 nm spectrophotometric detection to provide a sensitive and specific assay for enprostil and its major degradation products. The method satisfies the usual statistical criteria (recovery efficiency, response linearity, precision, lower quantitation limit) and performs well under various operating conditions as demonstrated by system suitability tests (analyte capacity factor dependence on column type, mobile phase composition, flow rate, and column temperature). We also demonstrate how a diode-array spectrophotometric detector
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