Development and Validation of a RP–HPLC Method For the Determination of Dosulepin In Pharmaceutical Formulation

A simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Dosulepin tablet dosage form. Isocratic elution at a flow rate of 1mL/min was employed on a symmetry Chromosil C18 (250x4.6mm, 5µm in particle size) at ambient temperature. The mobile phase consisted Methanol: Acetonitrile: 0.01M Phosphate buffer in the ratio of 55:20:25 (v/v/v). The UV detection wavelength was 230nm and 20 μL sample was injected. The retention time for Dosulepin was 3.46min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Dosulepin tablet dosage form and bulk drug.