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Development and validation of stability indicating UV spectrophotometric method for the estimation of tenofovir in its bulk and pharmaceutical dosage form | Abstract
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Abstract

Development and validation of stability indicating UV spectrophotometric method for the estimation of tenofovir in its bulk and pharmaceutical dosage form

Author(s): Ch. Srujani , D. Krishna Sowmya, Varanasi S. N. Murthy,A. Prameela Rani

Two simple, accurate, economic UV Spectrophotometric methods were developed for the estimation of Tenofovir in bulk and its tablet formulation. The λmax of Tenofovir was found to be 260nm. The first method involves the application of zero order derivative spectrophotometry where the zero order amplitudes were measured at absorption maxima of 234 nm for the determination of Tenofovir. The second method involves the calculation of Area under Curve which was done in the wavelength range of 250-270nm. The drug follows beer-lambert’s law in the concentration range of 5-25μg/ml for both the methods. The two methods were validated as per ICH guidelines and the validation parameters were found to be within the acceptable limit. Tenofovir was subjected to various stress conditions like acidic hydrolysis, alkaline hydrolysis and oxidation by using 0.1 N HCl, 0.1 N NaOH and 30% H2O2 v/v respectively. The proposed method for stability study shows that there was appreciable degradation found in alkaline hydrolysis stress condition of Tenofovir. Thus the developed methods were found to be stability indicating and can be used for the estimation of Tenofovir in bulk and pharmaceutical formulations.