Introduction: A simple, isocratic High Performance Liquid Chromatography (HPLC)
method has been modified for the qualitative and quantitative analyses of amisulpride related substances.
This method is based on using of RP-C8 (250 × 4.6 mm) column and a mixture of phosphate
buffer and methanol as mobile phase.
Materials and Methods: Various forced degradation studies were conducted to establish an impurity
profile for amisulpride raw material and in the tablet formula. Four degradation products were produced
upon exposing amisulpride to different degradation conditions (acidic, basic, oxidative, photolytic,
aqueous and thermal); three of them were already identified by British Pharmacopeia (BP).
Conclusion: The fourth new significant degradant was observed only under acidic degradation of
amisulpride (4 ml of 4 M hydrochloric acid solution at 70 °C for 5 hrs). Its structure was characterized
using LC-MS and NMR (1H NMR, 13C NMR and DEPT) techniques. Excipient components, examined
in this study, have no effect towards producing any extra new degradation products.