Analytical method development and validation of RP-HPLC method for estimation of Tenofovir Alafenamide

Analytical monitoring of the pharmaceutical products, or of specific ingredients within the product, its necessary to insure it’s safely and efficacy throughout all phases of its shelf-life, including storage, distribution and use. Essentially, the techniques of chromatography is based on the differences in the rate at which the components of the mixture move through a porous medium (called stationary phase) under the influence of same solvent or gas (called mobile phase). Forced degradation is a process that involves degradation of drug products and drug substances at conditions more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. The mobile phase of ACN: aqueous buffer (phosphate buffer pH 4.0) was selected after several permutations and combination. The flow rate was kept at 0.7 mL/min and 285 nm was selected as detection wavelength. Tenofovir Alafenamide was degraded in alkaline (0.1 N NaOH), acidic (0.1 N HCl), oxidative (3% H2O2), and thermal conditions. Tenofovir Alafenamide drug were almost stable in neutral conditions