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

• Autorzy: Ceylan Burhan , Tırıs Gizem , Tekkeli Evrim Kepekci , Önal Cem , Önal Armagan

Identyfikatory

DOI

10.1556/1326.2023.01167

• Języki publikacji: EN

Abstrakty

EN

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 min1. The linearity range is 10–150 ng mL1. 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 mL1 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.

Słowa kluczowe

EN

selexipag; HPLC-UV; pharmacokinetics; human plasma; pulmonary arterial hypertension

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2024
• Tom: Vol. 36, no. 3
• Strony: 273–--278
• Opis fizyczny: Bibliogr. 20 poz., rys., wykr.

Twórcy

autor

Ceylan Burhan

• Department of Pharmacognosy, Faculty of Pharmacy, Harran University, 63300 Sanlıurfa, Turkey

• https://orcid.org/0000-0003-3666-8187

autor

Tırıs Gizem

• Department of Analytical Chemistry, Faculty of Pharmacy, Bezmialem Vakif University, 34093 Fatih-Istanbul, Turkey

autor

Tekkeli Evrim Kepekci

• Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul Health and Technology University, Istanbul, Turkey

autor

Önal Cem

• Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul Health and Technology University, Istanbul, Turkey

autor

Önal Armagan

• Department of Analytical Chemistry, Faculty of Pharmacy, _Istanbul University, 34116 BeyazitIstanbul, Turkey

Bibliografia

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