ACTA CHROMATOGRAPHICA, cilt.36, sa.3, ss.273-278, 2024 (SCI-Expanded)
A novel simple and cost effective HPLC technique was presented for the quantification of selexipag (SLP) in human plasma sample and the technique's applicability to a pharmacokinetic investigation. Chromatographic separation was achieved with C1 8 (5 mu m 3 4.6 mm 3 150 mm) column, at 30 8C with isocratic elution, mobile phase composed of solution A (acetonitrile), and solution B (0.5% formic acid) (65:35 v/v) at flow rate 1.2 mL min-1. The linearity range is 10-150 ng mL-1. As sample preparation step human plasma was precipitated with acetonitrile and the detection was provided at 300 nm. The retention time is 8.20 +/- 0.02 min. LOD is found to be 3.3 ng mL-1 for drug. The method was applied to the analysis of SLP in human plasma with good recovery as 97.83%. Validation of the studied methods was carried out according to EMA guideline. The new method applied on a prototype pharmacokinetic study by administration of 800 mu g SLP to a healthy volunteer and parameters like AUC0-24, AUC0-infinity, Cmax, tmax, and t1/ 2 were assessed.