Determination of baloxavir marboxil in pharmaceutical preparations and spiked human plasma using its quenching action on acetoxymercuric fluorescein reagent: Assessment of greenness and whiteness

TL;DR

A new, eco-friendly method for measuring baloxavir marboxil in drugs and human plasma uses fluorescence quenching and outperforms older techniques in sustainability.

Contribution

A novel spectrofluorimetric method for BXM analysis with improved greenness and whiteness compared to existing chromatographic approaches.

Findings

The method showed linearity between 0.2 and 2 μg/mL for BXM analysis.

Mean recoveries of 101 ± 0.36% and 98.77 ± 0.65% were achieved in tablets and spiked plasma.

The proposed method demonstrated higher greenness and sustainability than four existing chromatographic techniques.

Abstract

A straightforward, reliable, and cost-effective spectrofluorimetric approach has been established for the analysis of baloxavir marboxil (BXM) in raw material, tablets, as well as spiked human plasma. The approach relies on BXM's quenching impact on acetoxymercuric fluorescein (AMF) fluorescence intensity. To improve the reaction, factors such as AMF's concentration, solution's pH, diluting solvents, and reaction time were examined and optimized. Linearity, range, accuracy, precision, LOD, and LOQ were all verified in compliance with ICH criteria. The concentration range was shown to be linear between 0.2 and 2 μg/mL. The technique was effectively utilized for BXM analysis in both its tablet as well as spiked human plasma, with mean % recoveries of 101 ± 0.36 and 98.77 ± 0.65, respectively. Two assessment models (AGREE and RGB-12) were used to compare the proposed process's greenness and sustainability to four previously published chromatographic techniques. Higher green and sustainability qualities were declared by the suggested approach than by earlier ones.

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