Stability Indicating Method Development and Validation of Selexipag in Bulk and Pharmaceutical Dosage form by using RP-HPLC

Abstract

A simple, efficient, precise, accurate & stable method has been developed and validated for determination of Selexipag in pharmaceutical tablet dosage form. An efficient high performance liquid chromatographic method was developed for Selexipag. The HPLC method was developed by using Symmetry C18 column; (150×4.6×5µ) column at 281nm, flow rate of 0.6ml/min., Injection volume of 20µl, column oven temperature of 25°C using equal volume of Methanol and Water used as mobile phase (50:50v/v). The retention times were found to be 2.682mins. The % purity was found to be 99.9 w/w. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The correlation coefficient (r2) was found to be 0.999%, recovery was 100.0%, %RSD for precision was found to be 0.2. The HPLC method was found to be accurate, precise, economical and reproducible. The method can be suggested for routine analysis and method can be recommended for determination of substance related, relative substance of Selexipag in pharmaceutical dosage form.