Abstract

VALIDATION OF STABILITY INDICATING RP-HPLC METHOD ANALYSIS FOR ASSAY OF AMISULPRIDE IN INJECTION

Ashlesha P. Bhagat*, Sonali S. Mahaparale and Reshma S. Kore

ABSTRACT

A simple and precise method was developed for the assay of Amisulpride from injection formulation. The solvent system and wavelength were optimized in order to maximize the sensitivity of the proposed method; Amisulpride shows the maximum absorbance at 280 nm. The separation was achieved on RP-HPLC Isocratic system equipped with HPLC Agilent 1200 series. The mobile phase was prepared with buffer pH 4.5: Acetonitrile: Methanol in the ratio of 75:20:5 O-phosphoric acid used for the pH adjustment (pH-4.5). The method was validated for accuracy, precision, linearity, specificity, stressed studies, robustness, etc. Linearity was observed in the concentration range of 70-130 % and gave mean correlation coefficient 0.999. The developed RP-HPLC method was found to be accurate, precise and was successful applied to a pharmaceutical injection formulation for qualitative estimation of Amisulpride.

Keywords: Amisulpride, RP-HPLC, Force degradation, method validation.