Eco-friendly spectrofluorimetric determination of peramapanel; application in pharmaceutical dosage forms and spiked human plasma

Abstract

A rapid and sensitive spectrofluorimetric method has been developed for the determination of perampanel in pharmaceutical preparations (assay method) and human plasma (bioanalytical method). The fluorescent product was measured at an excitation wavelength (λex) 294 nm and emission wavelength (λem) 430 nm. The assay method was validated as per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) guidelines. For the assay method, the fluorescence intensity versus concentration plot was found to be linear over the concentration range 25–175 ng/mL.In case of bioanalytical method, for the extraction of drug from human plasma, a lucid liquid-liquid extraction method using ethyl acetate was employed. The bioanalytical method was validated according to the United States Food and Drug Administration (USFDA) guidelines and it was applied for the quantification of the drug in human plasma with reasonable accuracy and precision. For the bioanalytical method, the fluorescence intensity versus concentration plot was found to be linear over the concentration range 5–150 ng/mL. The impact of endogenous compounds of the plasma matrix on drug fluorescence was also assessed. To assess the greenness of the developed method, Green Analytical Procedure Index (GAPI) and Analytical GREEnness (AGREE) tools were applied and it was inferred that the developed method adheres closely to the principles of green analytical chemistry.

Keywords

• Perampanel
• Spectrofluorimetry
• Tablets
• Human plasma
• Greenness evaluation