Friday , 21 June 2024

Development and Validation of a Stability Indicating UV Spectrophotometric Assay Method for Tenofovir Disoproxil Fumarate by Using Different Stress Conditions

K. Dharmendra, R. Surendra, C. Tejasri, D. Jagadeesh, B. Mohammed Ishaq*, D. China Babu,
Sreenivasulu Munna               
Department of Pharmaceutical Analysis, Narayana Pharmacy College, Chinthareddypalem, Nellore – 524002, A.P. India

Tenofovir disoproxil Fumarate (TDF), acyclic phosphonate nucleotide analogue, used as antiretroviral agents in the treatment of HIV-1 infection.  A stability indicating UV spectrophotometric method for the quantitative determination of Tenofovir in bulk and tablets was developed in present work. Distilled water was used as solvent. The wavelengths selected for the absorption correction method was 260 nm. The method was found to be linear between the ranges of 1-20 μg/ml. The mean percentage recovery was found in the range of 99.84%-99.91% at three different levels of standard additions. The precision (intra-day, inter-day) of method were found within limits (RSD <2%). The drug was subjected to acid, alkali, peroxide, UV and Heat degradation. Forced degradation studies of drug reveal good stability under the chosen experimental conditions. Thus, the proposed method was simple, precise, economic, rapid and accurate and can be successfully applied for the determination of Tenofovir in bulk and its tablet dosage form.
Keywords: Tenofovir, HIV, UV spectrophotometric, acid, alkali, peroxide, heat, tablet.

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