Molecular imprinted solid-phase extraction and analysis of Entecavir in presence of its induced degradation products and co-administered drug(s) in spiked human plasma, environmental three-color assessment and sustainability profiling

Abstract

Entecavir (ETV) is an antiviral drug that acts by blocking the active viral replication process due to its chemical similarity to guanine. Through this study, the extraction of ETV samples was described, for the first time, using a synthesized molecular imprinted polymer solid phase extraction (MISPE). The MISPE was characterized using TEM and FTIR analysis. A green RP- HPLC method was developed for the quantitation of ETV using C18 column and a mobile phase consisting of 0.1 % phosphoric acid in water and methanol in a gradient mode delivered at a rate of 1 ml/min at room temperature. The UV detection was carried out at 245 nm. The analytical method was validated according to ICH guidelines with a linear range of (5-250 μg/mL). The specific extraction of ETV was carried out successfully using MISPE in presence of its induced acidic, and basic degradation products. MISPE was also used for the extraction of ETV from spiked human samples containing the co-administered drug lamivudine. The MISPE showed excellent selectivity, reusability and high recovery percentages (>90 %) when compared to Oasis HLB cartridges. The analytical procedure was compared to the reported methods in terms of environmental three-color assessment (ETCA): greenness (using AGREE, AGREEMIP and ComplexMoGAPI), blueness (using BAGI), and whiteness (using RGB-12 algorithms). The proposed method transcended in saving energy, efficiency and applicability. The sustainability profile for the proposed method was established using the efficient-valid-green (EVG) framework displayed via its radar chart, that showed balance between the three pillars, and the NQS index that displays the excellent alignment of the method with the UN-17 SDGs.