DEVELOPMENT AND VALIDATION OF SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF SELEXIPAG IN API AND ITS BULK DOSAGE FORM

The present study was undertaken to develop and validate a simple, accurate, precise, reproducible and cost effective UV-Visible spectrophotometric method for the estimation of Selexipag. The solvent used throughout the experiment was Dimethyl sulphoxide (DMSO). Absorption maximum (λmax) of the drug was found to be 306 nm. The quantitative determination of the drug was carried out at 306 nm and Beer’s law was obeyed in the range of 5-25μg/mL. The approach of this work includes preliminary literature survey followed by the practical method development, applicable to be used on regular basis. The major outcomes of this method includes following: method was shown linear in the mentioned concentrations having line equation y =0.045x-0.039 with correlation coefficient R2 of 0.9963. The recovery values of Selexipag for 80%, 100% and 120% were found to be 99.16%, 99.7% and 99.00% respectively. The percent relative standard deviation (RSD %) of interday precision was 0.490% and intraday precision was 0.28%. The limit of detection and limit of quantification was 0.477μg/mL and 1.44μg/mL. The percent relative standard deviation of robustness and ruggedness of the method was 1.78 and 0.38% respectively. It can be concluded that proposed method was precise, accurate and cost effective and it could be applicable for quantitative determination of the bulk drug as well as dosage formulation.