Development and Validation of RP-HPLC Method for Estimation of Amisulpride

Abstract

A novel, simple, specific, accurate, precise method development and validated for the estimation of Amisulpride by RP-HPLC in
bulk and marketed formulation. A High Performance Liquid Chromatography WATERS Alliance 2695 separation module,
Software: Empower 2, 996 PDA Detector withInertsil ODS C18 (4.6mm x 250mm, 5µm) column, with mobile phase composition
of Methanol: Acetate Buffer (pH-4.2) (40:60% v/v) was used. The flow rate of 1.0 ml min-1 and effluent was detected at 280 nm.
The retention time of Amisulpride was 3.388 minutes. Linearity was observed over concentration range of 60-140ng ml-1. The
Limit of detection and limit of quantification was found to be 1.5ng ml-1 and 4.5ngml-1 respectively. The accuracy of the proposed
method was determined by recovery studies and found to be 98% to 102%. Then method was validated in terms of linearity,
accuracy, precision, (repeatability, intermediate precision) specificity (by assay), robustness and system suitability.Thus, the
validated method is can be successfully applied to routine analysis for regulate the quality. It also should be used for analytical
research purpose