Synthesis and Quantification of 2-(Diethylamino)-N-(2-methylphenyl)acetamide Nitrate

Abstract

A procedure for the synthesis of 2-(diethylamino)-N-(2-methylphenyl)acetamide nitrate (monomecaine) exhibiting a pronounced antiarrhythmic activity has been optimized. A procedure for its identification and quality control of the drug substance by HPLC has been developed, and the limit of detection of o-toluidine impurity therein has been estimated at 0.02%. Procedures for HLPC and extraction-titration quantification of monomekain in the drug substance have been proposed and validated. The obtained relative standard deviation (RSD) indicates good specificity, linearity, and precision of the developed procedures.