Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products

Pranavkumar Shah; Sanjay Hadiyal; Bhavin Dhaduk

Results in Chemistry (Dec 2023)

Stability indicating LC-MS/MS method and validation of Selexipag impurities and identification of its force degradation products

Pranavkumar Shah,
Sanjay Hadiyal,
Bhavin Dhaduk

Affiliations

Pranavkumar Shah: Department of Chemistry, School of Science, RK University, Rajkot-360 020, Gujarat, India
Sanjay Hadiyal: Department of Chemistry, Faculty of Science, Atmiya University, Rajkot-360 005, Gujarat, India
Bhavin Dhaduk: Department of Chemistry, School of Science, RK University, Rajkot-360 020, Gujarat, India; Department of Chemistry, Faculty of Science, Atmiya University, Rajkot-360 005, Gujarat, India; Corresponding author.

Journal volume & issue: Vol. 6
p. 101022

Abstract

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Selexipag belongs to a class of medicines known as IP prostacyclin receptor agonists used to treat pulmonary arterial hypertension. A simple and sensitive LC-MS/MS method has been developed for the identification of process related impurities in Selexipag API. The method was developed using a Zorbax C18 15 × 0.46 cm, 5μ column with a gradient program at 35 0C and flow rate of 1.0 mL/min. Detection was carried out by MS/MS with an ESI detector. Stress conditions were established by exposing the drug to acidic, alkaline, oxidative, thermal and photolytic stress condition. Identified and unidentified impurity was found when the fractions of acid and alkaline degradation product was analyzed by LC-MS/MS. The suggested methodology can be used to test the quality of Selexipag and identify the process-related impurities in pharmaceutical products.

Published in Results in Chemistry

ISSN: 2211-7156 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Science: Chemistry
Website: https://www.journals.elsevier.com/results-in-chemistry/

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