Four simple, precise and sensitive UV-spectrophotometric procedures were achieved for estimation of tenofovir alafenamide in the presence of its alkaline degradate. Dual wavelength was the first one which based on determination of the drug at 235.5 nm and 261.5 nm. First -derivative spectrophotometric method was the second one which the amplitude values were measured at 274 nm using Δλ of 8 nm and a scaling factor of 20. Third one was ratio difference which peak's amplitudes ratio spectra difference of tenofovir alafenamide was measured between 261.5 nm and 252 nm using devisor of 10 μg mL -1 of its alkaline degradate. While the last method was a first derivative of ratio spectra using Δλ = 8 nm and a scaling factor = 10 to measure the amplitude at 275.6 nm. The linearity range was 5-35 μg mL -1 in all procedures. The suggested procedures were effectively utilized for the estimation of the cited drug in bulk form as well as its dosage forms. According to ICH guidelines, all procedures were validated. Moreover, Analytical eco-scale and Green Analytical Procedure Index (GAPI) were used to estimate the greenness of the suggested methods compared with a reported one as two assessment tools.
In this study, a green stability indicating chromatographic methods were developed and validated for the quantitative determination of tenofovir alafenamide in the presence of its degradation products in bulk powder as well as in dosage forms. The first method was micellar UPLC in which separation was achieved on kinetex ® 1.7 μm HILIC 100A, LC column using an ecofriendly micellar mobile phase consisting (0.05 M sodium dodecyl sulphate and 0.05 M sodium dihydrogen phosphate, (pH 5.5) and 10% 1-propanol (70:30) at a flow rate of 1 mL min−1 with a UV detection at 210 nm. The second method depended on HPTLC method performed on HPTLC plates pre-coated with silica gel 60 F254 using a mobile phase consisting of n-butanol—acetic acid (7:3, v/v) and detection at 260 nm. Tenofovir alafenamide was subjected to stress conditions including alkaline and acidic degradation. Beer’ law was obeyed over the concentration range of 1–18 μg mL−1 and 0.1–4 μg/spot for micellar UPLC and HPTLC methods, respectively. Both methods are successfully applied to the analysis of the drug in its tablets and validated according to ICH guidelines. In addition, their greenness was assessed using three different tools indicating their least hazardous effect on the environment.
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