Green analytical chemistry approach for the determination of emtricitabine in human plasma, formulations, and solubility study samples

Abstract

This research involves the development and validation of a greener liquid chromatography approach for rapid estimation of an antiviral drug emitricitabine (ETT) in bulk drug, commercial formulations (capsules and oral solution), solubility samples, and human plasma. Waters HPLC system was used to perform chromatographic identification. On a nucleodur 150 mm × 4.6 mm RP C18 filled with 5 μm filler as a static phase, the chromatographic performance was attained. Methanol:ethanol (50:50 percent v/v) was used in the mobile phase. The proposed method was validated taking into consideration a variety of ICH-recommended test conditions for solution and FDA-recommended test conditions for plasma samples. The acceptable data of various parameters in plasma samples, including linearity (r2 = 0.999), accuracy (% recovery = 94.00–109.00), precision (intraday precision = 3.041–5.16% whereas interday precision = 3.19–4.93%), robustness (% RSD = 0.17–2.95) and sensitivity indicated its validity. The method's utility was confirmed by assaying the medication in commercial formulations (capsules and oral solution) as well as estimating solubility. The “analytical Greenness (AGREE)” scale for the proposed HPLC assay was obtained as 0.72, suggesting the reliable greener profile for ETT estimation. Overall, our findings imply that the suggested method can be used to analyze ETT in bulk drugs, pharmaceutical dose forms, and physiological fluids on a regular basis. Substituting innocuous and environmentally friendly solvents for commonly used hazardous solvents provides a superior alternative to more toxic drug analysis techniques.