Forced degradation and stability assessment of Tenofovir alafenamide

Abstract

This study presents a comprehensive evaluation of an analytical method for the quantification and identification of Tenofovir Alafenamide (TAF) and its related impurities in pharmaceutical formulations. The method exhibited outstanding performance, with exceptional sensitivity demonstrated through low limits of detection (LOD) and quantification (LOQ) values for TAF and various impurities. The LOD and LOQ values for TAF were determined to be 0.001% and 0.004%, respectively, underscoring the method's capability to detect minute concentrations. System suitability assessments, including LOD verification, linearity studies, relative response factor (RRF) determination, and accuracy assessments, provided a comprehensive understanding of the method's reliability and precision. The method showed a strong linear relationship between concentration and peak area, along with accurate recovery of added compound amounts at various concentration levels. Forced degradation studies further validated the method's specificity and robustness, with degradation peaks distinct from TAF and its specified impurities. Peak purity analysis confirmed the method's ability to accurately determine TAF in both untreated and treated test preparations. Additionally, system precision, method precision, and intermediate precision evaluations showcased the method's consistent and reproducible performance under various conditions and across different analysts. Stability assessments of the analytical solution, standard preparation, and mobile phase revealed the method's resilience to variations in flow rate and column oven temperature, with most parameters remaining within acceptable limits. In conclusion, this analytical method is a reliable tool for the precise quantification and identification of TAF and related impurities, meeting stringent acceptance criteria. Its robustness, precision, and specificity make it suitable for pharmaceutical quality control and research applications.