Aprotinin and aprotinin concentrated solution. Determination of impurities according to Ph. Eur. 0579, 0580

INTRODUCTION

CAPEL capillary electrophoresis system is a versatile analytical tool for pharmaceutical analysis of proteins, peptides and small molecules using capillary zone electrophoresis (CZE), capillary gel electrophoresis (CGE), capillary isoelectric focusing (CIEF) and micellar electrokinetic chromatography (MEKC). CAPEL capillary electrophoresis system is suitable for the analysis by capillary electrophoresis according to any monograph or general chapter from world pharmacopoeias.

European Pharmacopoeia monographs Aprotinin (0580) and Aprotinin concentrated solution (0579) prescribe the determination of related impurities by capillary zone electrophoresis.

The present method is used for the determination of aprotinin impurities in aprotinin and aprotinin concentrated solution according to European Pharmacopoeia monographs 0579 and 0580 (Tests section, Des-Ala-aprotinin and des-Ala-des-Gly-aprotinin) using CAPEL capillary electrophoresis system.