Kinetic Study on the Degradation of Meclophenoxate Hydrochloride in Alkaline Aqueous Solutions by High Performance Liquid Chromatography

A high performance liquid chromatographic method was developed and validated for determination of meclophenoxate hydrochloride (I) in the presence of its degradation product (p-chlorophenoxy acetic acid) (II). Separation of (I) from (II) was performed using a ZORBAX ODS column with a mobile phase consisting of 0.2% triethylamine in 0.01 M ammonium carbonate: acetonitrile (70:30 v/v). The method showed high sensitivity with good linearity over the concentration range of 50 to 400μg/ml. The method was successfully applied to the analysis of a pharmaceutical formulation containing (I) with excellent recovery. A kinetics investigation of the alkaline hydrolysis of (I) was carried out in sodium hydroxide solutions of 1, 1.5 and 2 N by monitoring the parent compound itself. The reaction order of (I) followed pseudo-first order kinetics. The activation energy could be estimated from the Arrhenius plot and it was found to be 12.331 kcal/mole.