ISOMERIC SEPARATION OF BERAPROST SODIUM USING AN ALPHA(1)-ACID GLYCOPROTEIN COLUMN

The separation of the four stereoisomers present in Beraprost sodium, a prostacyclin analogue, has been accomplished using an alpha1-acid gl ycoprotein stationary phase (Chiral AGP column). The stereoisomers are baseline resolved with a runtime of less than ten minutes. This chira l separation is used to quantitate the four Beraprost sodium stereoiso mers present in the bulk drug, tabletted formulations and in pharmacol ogical and toxicological studies. The mobile phase variables that were found to have an effect on the stereoisomeric separation were studied and include: ionic strength, type and concentration of organic modifi er, mobile phase pH and column temperature. Optimum stereoisomer separ ation was achieved on the Chiral AGP column. Calibration curves were l inear for all four stereoisomers over the range of 0.024 to 4.04 mug/m l using fluorescence detection (correlation coefficients were greater than 0.999). A detection limit of 0.004 mug/ml was found for each ster eoisomer. This assay has been used to determine the ratio of the four stereoisomers in the bulk drug as well as in the final formulated tabl ets.