A Contemporary Green Spectrofluorimetric Platform for the Simultaneous Determination of Naproxen and Esomeprazole in Pharmaceutical Formulation and Human Plasma

Abstract

Pharmaceutical quality control units are increasingly focused on developing new methods that can detect pharmaceutical substances in their formulations with high sensitivity, while also considering analytical performance and simplicity. In the current approach, a validated spectrofluorimetric method has been developed to simultaneously measure Esomeprazole magnesium (ESO) and Naproxen sodium (NAP) in their combined formulation and human plasma. The recommended method relies on quantifying the intensity of NAP's native fluorescence at 354.0 nm after excitation at 235.0 nm ensuring that ESO does not cause any interference. Whereas for ESO, which has no fluorescent activity, its determination was carried out by coupling with fluorogenic reagent, NBD-Cl, and the fluorescence intensity of the output of reaction was recorded at 538.0 nm, following excitation at 469.0 nm, with no interference from the NAP. Every factor influencing fluorescence intensity was examined. The method demonstrated linearity in concentration ranges from 40.0 to 1000 ng/mL for NAP and 20.0 to 2000 ng/mL for ESO with detection limits of 12.77 ng/mL for NAP and 6.01 ng/mL for ESO. Consequently, this method is highly effective for precisely determining these drugs. Lastly, the ICH requirements were followed, and the ecological impact was monitored using different metrics.