Analytical Method Development and Validation of Tenofovir Distroxil Fumarate (TDF) in Bulk and Formulations by using Folin-Ciocalteau Reagent through UV-Visible Spectroscopy

R. Nageswara Rao^*, Dr. D. Madhuri, U. Ramadevi, P. Poojitha, P. Sarala, S. Raj Kumar, T. Bhagyalakshmi, Y. Harshavardhan Yadav
Department of Pharmaceutical Analysis and Quality Assurance, Creative Educational Society’s College of Pharmacy, Kurnool, Andhra Pradesh

A B S T R A C T
A simple, economical, rapid, accurate, precise spectrophotometric method has been developed and validated according to ICH Q2 (R1) for the antipsychotic agent, Asenapine Maleate as active pharmaceutical ingredient (API). The U.V absorption maxima of Asenapine maleate was found to be at 275 nm wavelength using 0.1%IPA as a solvent. Linearity range was found to be 5-25μg/ml, with the correlation coefficient being more than 0.999. The relative standard deviation was found to be 0.001. The percentage recovery was within the range of 98% -102%, indicating the significant interference from the other ingredients in the formulation. The method can be applied for the routine analysis of Asenapine Maleate in pharmaceutical preparation.
Keywords: Asenapine Maleate, 0.1%IPA, UV Spectrophotometry and Validation.