Shweta Havele and Sunil R. Dhaneshwar

pp. 615 - 622

Abstract

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

Keywords

• HPLC
• forced degradation
• validation
• stress study
• tenoforvir disoproxil fumarate