Original Articles: 2015 Vol: 7 Issue: 6
Novel RP-HPLC method for the determination of Amisulpride in pure and pharmaceutical formulations
The core aim of present work was to develop a simple, precise, rapid and reproducible isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of Amisulpride (AMS) in pure and in tablet dosage form. An isocratic RP-HPLC was performed on a Phenomenex C18 column (250 x 4.6 mm, 5 micron size column, ambient temperature with mobile phase containing phosphate buffer duly adjusted to pH 4.1 with ortho phosphoric acid and acetonitrile in the ratio of 80:20 v/v. The flow rate was 1 mL/min and eluent was monitored at 227 nm. The chromatogram of AMS was found that the retention time is 5.601 min. The proposed method was linear to the concentration verses peak area responses which was found in the range of 2-10 μg/mL with R2 value of 0.9999. The reproducibility results of AMS were observed to be % 0.039 (% RSD) which speaks that this method can be reproducible for different tablets. The % RSD values were found to be less than 2 within the limit The percentage recoveries of active pharmaceutical ingredient from dosage forms ranged from 99.53 to 99.72 which indicate that the proposed method to be an accurate. The LOD and LOQ were found to be 0.0175 and 0.0577 respectively. The positive results of robustness of this method permits for extensive application for analysis of drugs. The % assay values for Sulpitac and Solian are 99.16±0.21and 99.85±0.11respectively. This method was specific as no interferences were detected at its retention time of peak drug. Therefore this RP-HPLC method is highly convenient, accurate, precise and economical with less retention time and can be used for the routine determination of AMS in pharmaceutical dosage form.