Stability Indicating Assay Method Development and Validation for Tenofovir Alafenamide Fumarate by RP-HPLC

Abstract

Aim: Development and validation of a stability indicating assay method for Tenofovir Alafenamide Fumarate tablets (25 mg strength) by RP-HPLC.Methodology: An efficient experimental design based on systematic scouting of all key components of the RP‐HPLC method and stress studies were performed. The separations were carried out on a C-18 reversed phase column (Inertsil ODS, 100 x 4.6 mm, 5 μ) using a mobile phase consisting of pH 6.0 ammonium acetate buffer and a solvent mixture (30:70) of ACN and THF in the ratio of 990:10 (Mobile phase A) and 500:500 (Mobile phase B) in a gradient elution mode at a flow rate of 1.50 mL/min and column oven temperature of 45°C. The wavelength of detection was 260 nm. Analytical validation parameters such as selectivity, linearity, accuracy, precision and robustness were evaluated as per ICH Q2 (R1) guidelines.Results: USP plate count and the USP tailing factor for the pure drug peak was found to be 9082 and 0.98 respectively which are well within the acceptance criteria. Forced degradation studies performed revealed that none of the degradants generated interfered with the pure drug peak.Conclusion: The proposed method can hence be used for routine analysis of Tenofovir Alafenamide Fumarate.