Green stability indicating UV- spectrophotometric techniques for estimation of tenofovir alafenamide in bulk form and dosage forms

Abstract

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.

Central composite design driven optimization of sustainable stability indicating HPLC method for the determination of Tigecycline and greenness assessment

“…Because the GHS risk pictograms are printed on the bottles of the reagents, it is easy to determine the level of danger connected with using the chemicals. [41][42][43]52 The interpretation of the GAPI pentagrams for the proposed chromatographic approach and its comparison with the reported methods [33][34][35] are described in Table 8 and illustrated in Figure 8. The recommended procedure was more environmentally friendly than the reported methods.…”

Central composite design driven optimization of sustainable stability indicating HPLC method for the determination of Tigecycline and greenness assessment

“…Because the GHS risk pictograms are printed on the bottles of the reagents, it is easy to determine the level of danger connected with using the chemicals. [42][43][44]53 The interpretation of the GAPI pentagrams, NEMI, and Eco-scale assessment of the proposed chromatographic approach and its comparison with the reported methods [33][34][35][36][37]39,40 are described in Tables 8 and 9. The recommended procedure was iii Basic and oxidative stress conditions in method 35 were obtained in 10 and 15 min, but the acidic condition in 60 min.…”