Development and Validation of Stability indicating Rp-Hplc Method for Amisulpride in Bulk and Pharmaceutical Formulation

A simple, sensitive, rapid, robust and reproducible method for the determination of amisulpride using paracetamol as internal standard (IS) in bulk and pharmaceutical formulation was developed using reverse phase high performance liquid chromatographic method. The analysis was performed on C18 (250 4.6 mm, 5 mcm) column with a mobile phase consisting of 0.03 M potassium dihydrogen ortho phosphate buffer (pH 6.5), acetonitrile in the ratio of 67:33 (V/V) with a flow rate of 1 mL/min. The analyte was monitored with UV detector at 263 nm. In the developed method amisulpride elutes at retention time of 4.4 min and paracetamol (IS) at 3.3 min. The proposed method is having linearity in the concentration range from 10-100 mcg/mL of amisulpride. The method was validated with respect to system suitability, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery),ruggedness, robustness, stability, forced degradation studies (specificity). The proposed method can be readily utilized for bulk drug and pharmaceutical formulations of amisulpride.