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

Said, Noha; Nasr, Zeinab; Abd El Razeq, Sawsan

doi:10.21608/aijpms.2021.54658.1032

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

Document Type : Original research articles

Authors

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo 11754, Egypt

10.21608/aijpms.2021.54658.1032

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.

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