IMPURITY PROFILING AND STABILITY-INDICATING UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF AVACOPAN

A simple, rapid, precise, sensitive and reproducible ultra performance liquid chromatography (UPLC) method has been developed for the quantitative analysis of Avacopan and its impurities. Chromatographic separation of Avacopan and its impurities was achieved on Waters Acquity-e2695, by using Waters acquity UPLC BEH Shield RP-18 100mmx2.1, 1.7µm column and the mobile phase containing Ammonium formate pH-3.0/OPA & Acetonitrile in the ratio of 30:70% v/v. The flow rate was 0.2 ml/min; detection was carried out by absorption at 241nm using a photodiode array detector at ambienttemperature. The number of theoretical plates and tailing factor for Avacopan and its impurities were NLT 2000 and shouldnot more than 2 respectively. %Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Avacopan and its impurities and study of its stability. Keywords: UPLCAvacopan,Impurity-A,Impurity-B