A novel HPLC method for selexipag in human plasma and application to a prototype pharmacokinetic study
Yükleniyor...
Tarih
2023
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Akademiai Kiado
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
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 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 μg SLP to a healthy volunteer and parameters like AUC0–24, AUC0–∞, Cmax, tmax, and t1/2 were assessed.
Açıklama
Anahtar Kelimeler
Selexipag, HPLC-UV, Pharmacokinetics, Human Plasma, Pulmonary Arterial Hypertension
Kaynak
Acta Chromatographica
WoS Q Değeri
Q3
Scopus Q Değeri
Q3
Cilt
36
Sayı
3
Künye
Ceylan, B., Tırıs, G., Kepekçi Tekkeli, Ş. E., Önal, C., & Önal, A. (2023). A novel HPLC method for selexipag in human plasma and application to a prototype pharmacokinetic study. Acta Chromatographica, 36(3), pp. 273-278. https://doi.org/10.1556/1326.2023.01167
