A new HPLC method for selexipag analysis in pharmaceutical formulation and bulk form

Year 2023, Volume: 2 Issue: 2, 53 - 58, 28.08.2023

Saniye Özcan , Egemen Güvenç Öğüt , Serkan Levent , Nafiz Öncü Can

https://doi.org/10.55971/EJLS.1320502

Abstract

Selexipag is a new non-prostanoid prostacyclin receptor agonist used to treat pulmonary arterial hypertension. Selexipag is a long-acting IP receptor agonist with a shorter half-life than all other licensed drugs targeting the prostacyclin pathway, mostly administered intravenously or by subcutaneous infusion or inhalation. In this study, a new high performance liquid chromatography (HPLC) method was developed to analyze Selexipag in bulk and pharmaceutical formulations. The method used a column with Supelco Ascentis® Express (Sigma Aldrich, USA) model phenyl hexyl functional group (100×4.6 mm, ID, 2.7µm). Chromatographic separation was in isocratic elution mode, and the mobile phase mixture was acetonitrile containing 0.1% formic acid: water containing 0.1% formic acid (60:40, v/v) ratio. The method was linear in the concentration range of 15.7-117.6 µg/mL, and the LOD and LOQ were obtained as 2.4 and 3.1 µg/mL, respectively. Various method parameters have been tested according to the ICH Q2(R1) manual, and it is a method with high accuracy and precision. Therefore, the developed method is suitable for selexipag’s bulk and pharmaceutical formulation analysis.

Keywords

Bulk, HPLC, Pharmaceutical formulation, Selexipag

Supporting Institution

Anadolu University Scientific Research Projects Fund Commission

Project Number

2005S039

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