High Performance Liquid Chromatographic Determination of Sertraline in Presence of Its Degradation Product

Abstract

A simple, stability – indicating, reversed phase liquid chromatographic method has been developed for the determination of sertraline in the presence of its oxidative degradation product. Reversed phase chromatography was conducted using a phenyl (250 × 4.6 mm id) stainless steel column at ambient temperature with UV-detection at 226 nm. A mobile phase consisting of potassium dihydrogen phosphate buffer: acetonitrile (50:50, v/v) adjusted to pH 4.5 with phosphoric acid, has been used for the separation of sertraline and its oxidative degradation product at a flow rate of 1 ml/min. The calibration curve was rectilinear over the concentration range of 1–20 μg/ml with a detection limit (LOD) of 0.09 μg/ml, and quantification limit (LOQ) of 0.27 μg/ml. The proposed method was successfully applied for the analysis of sertraline in its tablets, with mean % recoveries of 100.17 ± 0.62 for sertraline in pure form and 100.14 ± 0.68, 100.29 ± .77, and 100.06 ± 0.67 for seserine®, serlift®, and sirto® tablets, respectively. The obtained results were favorably compared with those obtained by a reference method. The drug was exposed to forced alkaline, acidic, hydrolytic, and oxidative degradation according to the ICH Guidelines. Moreover, the method was utilized to investigate the kinetics of the photoinduced oxidative degradation of the drug. The first-order rate constant, half-life time, and activation energy of the degradation reaction were calculated.