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Aggarwal NN
Aggarwal NN
NGSM Institute of Pharmaceutical Sciences of Nitte-Deemed to be University,
Paneer, Deralakatte, Mangalore-575 018, Karnataka
India
Publications
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Research Article
Stability Indicating Assay Method Development and Validation for Tenofovir Alafenamide Fumarate by RP-HPLC
Author(s): Aggarwal NN, Bhat KI and Jacob JTAggarwal NN, Bhat KI and Jacob JT
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.. View More»
DOI: 10.4172/2153-2435.1000601