Research Information System
Microchemical Journal, vol.225, 2026 (SCI-Expanded, Scopus)
Selexipag is utilized to extend the progression of pulmonary arterial hypertension (Amara Babu et al., 2021 [1]). In this study, analytical methods were developed for the determination of selexipag. The method was optimized, then validated according to the ICH Q2(R2) guideline. An Ascentis® Express Phenyl-Hexyl (10 cm × 4.6 mm, 2.7 μm) column was used for separation, with a mobile phase consisting of acetonitrile and 20 mM ammonium format buffer solution (pH 3.8) in different ratios for each method. Moreover, the stability and degradation behavior of selexipag in various media were investigated, and the resulting degradation products were qualitatively characterized using an HRMS detector. Four degradation products were identified, two of which possess registered CAS numbers. Based on these findings, a plausible degradation pathway for selexipag was proposed. The analytical method was accordingly optimized to achieve effective separation of selexipag from its degradation products. Additionally, molecular docking studies were performed for selexipag and the newly identified products to assess their potential interactions. The method had a linear range of 3.04–121.44 (μg/mL) for HPLC and 0.13–5.05 (μg/mL) for LC-MS. For the accuracy study, the concentration of selexipag in the placebo of the pharmaceutical formulation of UPTRAVI® was determined. Finally, the whiteness of the proposed methods was calculated and compared with previous methods using the White Analytical Chemistry (WAC) tool.