A Novel Improved RP-HPLC Method for the Estimation of Dothiepin Hydrochloride in Bulk and Pharmaceutical Dosage Form

Abstract

A Simple and precise reverse phase high performance liquid chromatography(RP-HPLC)method was developed and validated for the estimation of Dothiepin hydrochloride in bulk and pharmaceutical dosage form. The optimization is carried out on an Inertsil ODS 3 (250×4.6mm, 5μ particle size) long column with a mobile phase of Formic acid(0.02%): Acetonitrile in the ratio of 72:28v/v at a flow rate of 1ml/min with UV detection at 230 nm using LC solution software. The Linearity of Dothiepin hydrochloride was observed in the concentration range of 2-10μg/ml (R 2 =0.999). The proposed method has shown consistent recovery of Dothiepin 99.41-100.85% with the labeled amount in the pharmaceutical formulation. The proposed method was successfully applied for the quantification of active drug in tablet dosage form.