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

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 [C.sub.18] (5 [micro]m x 4.6 mm x 150 mm) column, at 30 [degrees]C 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.sup.-1]. The linearity range is 10-150 ng [mL.sup.-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 [+ or -] 0.02 min. LOD is found to be 3.3 ng [mL.sup.-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 [micro]g SLP to a healthy volunteer and parameters like [AUC.sub.0-24], [AUC.sub.0-[infinity]], [C.sub.max], [t.sub.max], and [t.sub.1/2] were aBeBed.