Abstract
Abstract Enprostil, an E-type prostaglandin analog, is formulated as a 0.3 mM propylene carbonate solution filled into soft elastic gelatin capsules. A characteristic structural feature of enprostil is the presence of two unresolved chiral centers, yielding a drug molecule that exists as two diastereomeric pairs of enantiomers. This report describes an HPLC method for quantitatively determining the relative amounts of enprostil diastereomers in soft elastic gelatin capsules. Using a Spherisorb ODS 5 μym, 250 × 4.5 mm column and a mobile phase mixture of 59:40:1 methanol:water:tetrahydrofuran separates the enprostil diastereomeric pairs and also resolves the enprostil diastereomers from potential interferences arising from placebo and drug degradation. The method performs well as evidenced by the usual statistical tests for: response linearity, recovery efficiency, precision, and lower quantitation limit. Also, the demonstrated dependence of chromatographic retention on mobile phase composition and system ...
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