Synthesis and standardisation of aceclofenac ethyl ester and aceclofenac benzyl ester as related aceclofenac impurity

Abstract

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID). This study aimed to synthesise aceclofenac ethyl ester (E impurity) and aceclofenac benzyl ester (F impurity) of the drug aceclofenac at a laboratory scale and establish impurity criteria using high-performance liquid chromatography (HPLC) to create reference substances for E and F impurities. They were synthesised through the esterification of aceclofenac and diclofenac sodium in dimethyl formamide (DMF), optimised with yields of 96 and 66%, respectively...