Abstract
A reliable and sensitive isocratic stability indicating RP-UPLC method has been developed and validated for quanti-tative analysis and content uniformity study of Amisulpride in tablets. An isocratic method for analysis of Ami-sulpride 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 consis-ted of Buffer-ACN (50:50 v/v), (Buffer: 2 mL Ortho phosphoric acid in 1L water). The drug was subjected to oxida-tion, 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. Ac-curacy (recovery) was between 99 to 101 %. Degradation products resulting from the stress studies did not interfe-re with the detection of Amisulpride the assay is stability-indicating.
Keywords: Yöntem validasyonu, Amisülprid, Içerik uygunlugu, UPLC.
