METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE

Abstract

Method of determination of potassium cyanate in carbamylated darbepoietin alpha drug substance was developed. The method is based on derivatization of cyanate by methyl ester of anthranilic acid followed by formation bicyclic derivative (1-H,3-H-quinazolinedione), which is able to fluorescence. Application of this method to determine potassium cyanate in protein drugs was investigated. Interference of excipients on this method was evaluated. The validation was performed: specificity, linearity, accuracy, precision, limit of quantitication.

Keywords

• cyanate
• methyl anthranilate
• derivatization
• fluorimetry
• darbepoietin
• carbamylated darbepoietin