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


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Ceylan B., Tlrls G., Kepekci Tekkeli S. E., Önal C., ÖNAL A.

Acta Chromatographica, 2023 (SCI-Expanded) identifier

  • Publication Type: Article / Article
  • Publication Date: 2023
  • Doi Number: 10.1556/1326.2023.01167
  • Journal Name: Acta Chromatographica
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Biotechnology Research Abstracts, CAB Abstracts, Veterinary Science Database
  • Keywords: HPLC-UV, human plasma, pharmacokinetics, pulmonary arterial hypertension, selexipag
  • Istanbul University Affiliated: Yes

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. Chromatographic separation was achieved with C18 (5 μm × 4.6 mm × 150 mm) column, at 30 °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-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 μg SLP to a healthy volunteer and parameters like AUC0-24, AUC0-∞, Cmax, tmax, and t1/2 were assessed.