U. Ramadevi*1, Dr.D.Madhuri1, R.Nageswara rao1, K. Lakshmi prasanna1, A. Sumanth Prasad Rao1, A.Vasundhara1, B. Shiva kumar1, K.Srinivasulu1
Department of Pharmaceutical Analysis and Quality Assurance, Creative Educational Society’s College of Pharmacy, Kurnool, Andhra Pradesh, India
A simple, economical, rapid, accurate, precise UV- Visible spectrophotometric method has been developed and validated according to ICH guidelines for the Tenofovir Distroxil Fumarate (TDF) as active pharmaceutical ingredient (API) by UV–Visible Spectrophotometric method. The absorption maximum of TDF was found to be at 763nm wavelength using in ethanol water as a solvent. Linearity range was found to be 5-25ug/ml, with the correlation coefficient being more than 0.999. The relative standard deviation was found to be < 2 %. The percentage recovery was within the range of 98% -105%, indicating that there is no significant interference from the other ingredients present in the formulation. The molar absorptivity ans sandell’s sensitivity were found to be 0.278X104L mol-1cm-1 and 17.6 µg/cm2 and the of drug: FC reagent was found to be 1:2 in distilled water. The method can be applied for the routine analysis of TDF as API in pharmaceutical preparation.
Key words: Tenofovir Disproxil Fumarate, Ethanol, Routine analysis, UV–Visible Spectrophotometry