Quantitative determination of alprostadil (PGE1) in bulk drug and pharmaceutical formulations by high-performance liquid chromatography

✍ Scribed by P.H. Zoutendam; P.B. Bowman; T.M. Ryan; J.L. Rumph

• Publisher: Elsevier Science
• Year: 1984
• Tongue: English
• Weight: 450 KB
• Volume: 283
• Category: Article
• ISSN: 1873-3778
• DOI: 10.1016/s0021-9673(00)96262-9

✦ Synopsis

An adsorption high-performance liquid chromatographic method suitable for the quantitative determination of the purity of alprostadil (prostaglandin El) 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-PGEi, ll-epi-PGEi, 15epi-PGEi, PGE2, 5,6-trans-PGEz, 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.