A novel HPLC method for selexipag in human plasma and application to a pharmacokinetic study

Abstract 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. C18 (5 µm x 4.6 mm x 150 mm) column was used at 30°C with a mobile phase consisted of acetonitrile: % 0.5 formic acid (65:35 v/v) at 1.2 mL min− 1 flow rate. The linearity range is 10–125 ng mL− 1. As sample preparation step human plasma was precipitated with acetonitrile and the detection was provided at 300 nm. LOD is found to be 3.3 ng mL− 1 for drug. Validation of the studied methods was carried out according to EMA guideline. The new method applied on a pharmacokinetic study by administration of 800 mg SLP to a healthy volunteer and parameters like AUC0 − 24, AUC0−∞, Cmax, tmax, and t1/2 were assessed.