Current Issue : January-March Volume : 2024 Issue Number : 1 Articles : 1 Articles
A validated reverse phase high performance liquid chromatography method was developed to assess the stability of selexipag. The wavelength chosen for quantification was 271 nm. The approach has been confirmed to be linear, accurate, precise, robust and has established limits of detection and quantitation. Linearity was detected within the concentration range of 25-150 μg/ml for selexipag. The RP-HPLC separation was carried out using a Hypersil ODS C18 column (250×4.6 mm, 5 μm) with a mobile phase consisting of 0.1% orthophosphoric acid buffer (pH 2.5) and methanol in a ratio of 60:40 v/v. The flow rate was set at 1 ml/min. The retention time for selexipag was determined to be 2.1 min. During forced degradation studies, the selexipag underwent hydrolysis (acid and base hydrolysis), exposure to H2O2, heat degradation and light degradation. The proposed method precisely calculates the quantities of selexipag while accounting for every degradant produced throughout the forced degradation experiment. The established procedure was uncomplicated, precise and cost-effective, suitable for the determination of selexipag in tablet form....
Loading....