Development and validation of a stability-indicating lc method for the determination of tenofovir disoproxil fumarate in pharmaceutical formulation
Shweta Havele and Sunil R. Dhaneshwar
Songklanakarin Journal of Science and Technology
The present study describes the degradation of tenoforvir disoproxil fumarate (teno) under different prescribed stress conditions (hydrolysis, oxidation, dry and wet heat and photolysis) following the International Conference on Harmonization and application of a specific and selective stability-indicating reversed-phase high–performance liquid chromatography (HPLC) assay. Separation of drug and degradation products was successfully achieved on C18 analytical column using methanol: water (60:40, v/v) at a flow rate of 1.0 ml/min and detection at 260 nm, the mass balance was found to be close to 100.4%. The developed HPLC method was validated with respect to linearity, accuracy, precision, robustness, and accuracy.
HPLC, Pharmaceutical, Formulation,Tenofovir Disoproxil fumarate, Degradation, Validation