Method for Purity Determination ofAlprostadiI by Micellar Electrokinetic Capillary Chromatography with Signal Enhancement.
Matson, Michael T.
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Two related procedures based on micellar electrokinetic chromatography (MECC), a variant of capillary electrophoresis (CE), were developed and validated for purity determination of alprostadil (PGE I). The techniques of polarity-reversed sample stacking and high sensitivity optical cell enhancement were used to obtain increased signal response. Separations were conducted on fused silica capillaries with a run buffer comprised primarily of sodium phosphate salts, sodium dodecyl sulfate, and isopropanol. The separations both take about 15 min with an additional 4-6 min required to rinse and fill the capillary with fresh run buffer. The precision for both techniques meets current validation expectations, generally below 1%, always below 2%. A benefit of the MECC procedures is a 20 min run time versus a 50 min run time for a newly implemented HPLC assay. In short, these two new MECC procedures achieve performance comparable to HPLC, and thereby offer a reliable, orthogonal means of assay for alprostadil.