Method Development and Validation of Stability Indicating HPLC Assay for the Determination of Tenofovir Alafenamide Fumarate in Tablet Formulation

Abstract

This manuscript describes the development and validation of a simple, isocratic, precise and accurate HPLC method for the assay of Tenofovir alafenamide fumarate (TAF) in tablet formulations. The previous reported methods were costly, less efficient, utilized temperature and pH conditions for method development, making it more complex while this method utilizes lower quantity of mobile phase, an C18 column to improve efficiency, retention and reproducibility of the method without using the conditions of temperature and pH. The mixture of buffer (0.1% trifluoroacetic acid): ACN (65:35 v/v) was used as a mobile phase with isocratic elution. C18 column (Syncronis C18 250 x 4.6 mm) having particle size 5μm was used at a flow rate of 1mL/min. The suggested method described a linearity range of 30-80 μg/mL and the correlation coefficient equals to 0.997 that determines the linearity between the concentration and absorbance. The tailing factor and plate count were found to be 1.03 and 12110 under the acceptable limits. According to ICH Q2 (R1) guidelines, all parameters were validated except LOD and LOQ. The drug was forcefully degraded by acid, alkali and oxidation. Validated result showed that the method was precise, cheap, isocratic, definite, less time consuming, robust and was degraded within the acceptable limits. No interference was observed in the placebo and blank injections hence the method proved to be specific. The optimum RT (retention time) value was found to be 5.8 min. A simple, efficient and economic method was developed with no use of temperature and pH. The suggested method can be applied as a market analysis of TAF in the tablet form.