Greenness assessment of micellar spectrofluorometric approach for determination of Elagolix: application to dosage form, content uniformity and human plasma

Abstract

Ecological, sensitive, fast and economic approaches are the main aspects in quality control of pharmaceutical products. Elagolix (ELG) is an orally non-peptidic GnRH antagonist, recently approved drug by Food and drug administration in 2018 for treatment of pain associated with endometriosis. A green, and sensitive method was developed and validated for determination of ELG based on micellar spectrofluorometric approach. Many factors were studied to enhance the fluorescence intensity of ELG and the highest sensitivity was obtained upon using 1% Sodium dodecyl sulphate (SDS) at 438 nm after excitation at 270 nm. A linear relationship was obtained over a range of 50–1000 ng mL−1 between ELG concentration and corresponding fluorescence intensity. The developed method was validated according to ICH guidelines and successfully applied for testing the content uniformity and determination of ELG in pharmaceutical dosage forms with percentage recovery 99.31 ± 1.98. Furthermore, the capability of the method due to its high sensitivity to determine ELG in human plasma with percentage recoveries in a range of 98.54–100.46. The greenness of the method was investigated using three different approaches; Analytical Procedure Index (GAPI), Analytical Eco-Scale and Analytical Greenness Metric (AGREE).