STABILITY INDICATING REVERSE PHASE ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR TAFENOQUINE SUCCINATE IN THE PRESENCE OF DEGRADATION PRODUCTS AND APPLICATION TO GREEN ANALYTICAL CHEMISTRY

Abstract

Tafenoquine Succinate is the succinate salt form of tafenoquine, an orally bioavailable 8-aminoquinoline derivative, with antimalarial activity. In this study, we developed and validated a method to determine Tafenoquine Succinate and its related impurities in pharmaceutical dosage forms using a reverse phase-UPLC technique. All the impurities are separated in the analytical column Waters X bridge C18 (50mm X 4.6 mm, 3.5 µm) using a suitable mobile phase was 0.1% Formic acid and Ethanol in the 55:45 v/v isocratic mode. The flow rate is 0.3 mL/min with the gradient programme the injection volume is 3 µL, detection at 215 nm in UV and the total run time is 10 minutes. The samples were made for forced degradation under hydrolysis, oxidation, thermal and photolytic conditions. The method was validated according to the international conference on Harmonisation (ICH) guidelines and found to be specific, linear, rugged, robust and accurate. The method was linear from LOQ to 150% concentration level for all impurities. The recovery was performed from LOQ to 150% concentration, and the mean recovery was found acceptable. The degradation and validated study results indicate its stable nature. Therefore, this method can be used in pharmaceutical research and development and quality control departments. Green analytical chemistry tools are used to assess the greenness of the method and calculated using GAPI, AGREE and Eco-scale and found excellent green of >75%.