Quantitative determination of alprostadil (PGE) in bulk drug and pharmaceutical formulations by high-performance liquid chromatography

An adsorption high-performance liquid chromatographic method suitable for the quantitative determination of the purity of alprostadil (prostaglandin E1) bulk drug and of the concentration of alprostadil in Prostin V.R. Pediatric Sterile Solution is described. A variety of isomers and related compounds including 8-iso-PGE1, 11-epi-PGE1, 15-epi-PGE1, PGE2, 5,6-trans-PGE2, and 8-iso-PGE2 are separated from alprostadil and are quantifiable. The 2-naphthacyl ester derivatives are employed and derivatization conditions providing maximum response are described.