Original article STABILITY INDICATING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR ASSAY AND CONTENT UNIFORMITY STUDY OF AMISULPRIDE IN PHARMACEUTICAL DOSAGE FORM

A reliable and sensitive isocratic stability indicating RP-UPLC method has been developed and validated for quantitative analysis and content uniformity study of Amisulpride in tablets. An isocratic method for analysis of Amisulpride was achieved on C18 (100x2.1) mm particle size 1.7 µ columns at of 0.20 mL/min flow rate within shorter runtime of 3 min. Photodiode array detector was used to monitor the eluate at 280 nm. The mobile phase consisted of Buffer-ACN (50:50 v/v), (Buffer: 2 mL Ortho phosphoric acid in 1L water). The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. Response was a linear function of drug concentration in the range of 20-80 µg/ml (r2= 0.999) with a limit of detection and quantification of 0. 1 and 0.3 µg/mL respectively. Accuracy (recovery) was between 99 to 101 %. Degradation products resulting from the stress studies did not interfere with the detection of Amisulpride the assay is stability-indicating.