A highly sensitive micelle-sensitized spectrofluorimetric approach for analysis of montelukast in dosage forms and human plasma: Greenness assessment and application to content uniformity testing

Abstract

In this work, a highly sensitive, rapid, affordable, and green micellar-enhanced spectrofluorimetric method was developed for the estimation of montelukast in its tablets and human plasma for the first time. After excitation at 224 nm, a micellar solution of cetrimide containing montelukast produced high native fluorescence emission at 404 nm. A 3-fold enhancement of the drug's fluorescence intensity and quantum yield, as well as the method's sensitivity, was produced using cetrimide as a micellar system. The experimental parameters influencing the spectrofluorimetric behavior of the studied drug were carefully investigated. The quantum yield of montelukast was also computed and found to be as high as 20 %. A straight-lined calibration plot was obtained over the concentration range of 50.0–1000.0 ng/mL. The proposed method showed high sensitivity down to the nanogram level with quantitation and detection limits of 34.68 and 11.45 ng/mL, respectively. The method was successfully applied for the analysis of the studied drug in its tablets with high % recoveries and low %RSD values. As the proposed fluorimetric method is highly sensitive and selective towards montelukast, it could successfully test the content uniformity of its tablets following the guidelines of the British Pharmacopoeia. Montelukast was also successfully determined in spiked human plasma samples due to the increased sensitivity of the method. The greenness profile and ecofriendliness of the proposed method were verified using two different green metrics, including AGREE and GAPI, which demonstrated the excellent greenness of the method. The developed method was validated according to ICH Q2 (R1) guidelines.