Method Development and Validation of RP-HPLC Method For Determination of Selexipag in Bulk and Formulation

The present study described a new, simple, accurate and precise development for estimation of selexipag by RP Agilent Tech. Gradient System with Auto injector, UV (DAD) & Gradient Detector Reverse Phase (Agilent) C18 column (4.6mm x 250mm;5µm), a 20µl injection loop and UV730D Absorbance detector and running chemstation 10.1 software. Methanol: water (0.1%OPA), (75:25) v/v, pH 3.was used as the mobile phase for the method. The detection wavelength was 270 nm and flow rate was 0.8 ml/min. In the developed method, the retention time of Selexipag was found to be being 5.268 min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So, the proposed methods can be used for the routine quality control analysis Selexipag in bulk drug as well as in formulations. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The described HPLC method was successfully employed for the analysis of selexipag. The method provides selective quantification of Selexipag This developed RP-HPLC method for estimation of Selexipag is accurate, precise, robust and specific.