• Citer

Validation of a fluorimetric assay for 4-aminophenol in paracetamol formulations.

par Dejaegher, Bieke ;Bloomfield, M S;Smeyers-Verbeke, Johanna;Vander Heyden, Yvan
Référence Talanta, 75, 1, page (258-265)
Publication Publié, 2008

Article révisé par les pairs

• Accès en ligne
• Détails
• Contenu
• Statistiques

Résumé :

4-aminophenol (4-AP) is the primary degradation product of paracetamol (PARA). According to the European Pharmacopoeia, 50 ppm 4-AP/PARA is the specification limit of 4-aminophenol in paracetamol drug substance. For drug products, often higher specification limits, such as 1000 ppm 4-AP/PARA are applied. This paper describes a fluorimetric method to quantify the low amount of this degradant (50 ppm) in a pharmaceutical preparation, i.e. in paracetamol tablets. The fluorimetric method was validated and the linearity, precision, trueness, range, limit of detection and limit of quantification were determined. They were found acceptable to assay the low amounts of 4-aminophenol in paracetamol tablets.