Determination of epoprostenol sodium (prostaglandin I2 sodium) and related prostaglandins in epoprostenol sodium bulk drug by high-performance liquid chromatography

Abstract Two complementary high-performance liquid chromatographic assays for the quantitation of epoprostenol sodium (PGI 2 ) and seven potential impurities in epoprostenol sodium bulk drug are described. A reversed-phase assay using a mobile phase of acetonitrileborate buffer (pH 9.5), an octadecylsilane column and ultraviolet detection at 214 nm is employed for the quantitation of PGI 2 , and its isomer, Δ6-PGI 1 . An adsorption system employing a dimethylsulfoxide-methylene chloride mobile phase is used to separate and quantitate the other compounds as their p -bromophenacyl derivatives. In this case, the effluent is monitored at 254 nm, and impurity levels are quantitated by area percent assuming equal response for all compounds. Chromatographic specificity and performance characteristics for both procedures are described.