ANALYSIS OF RECOMBINANT HUMAN GROWTH-HORMONE AND ITS RELATED IMPURITIES BY CAPILLARY ELECTROPHORESIS

A convenient free solution capillary electrophoretic method is describ ed for the simultaneous quantitation of human growth hormone (hGH) and its related impurities in pharmaceutical preparations. The separation of the cleaved form, the monodeamidated form and two new compounds wh ich may arise from post-translational modifications in Escherichia col i-a succinylated hGH with a blocked amino terminus and a modified hGH having a His to Gin replacement at sequence position 18-is described. The proposed capillary electrophoretic method shows good specificity, linearity and precision. A limit of detection of 0.03% was calculated for the impurities.