Abstract

SIMPLE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF TENOFOVIR AND EMTRICITABINE IN TABLET DOSAGE FORM

*Syeda Kulsum and G. Vidya Sagar

ABSTRACT

A simple, precise and selective method was developed for the determination of Tenofovir fumarate and Emtricitabine in tablet formulation. This method involves the application of simultaneous equation spectrophotometry method where the lambda max (λmax) measured at 296nm and 271nm for determination of Tenofovir and Emtricitabine. The Spectrophotometric method using diluents comprising methanol and acetonitrile in ratio (70:30). Different variables affecting the method were carefully investigated and optimized. Reliability and analytical performance of the proposed methods, including linearity, precision, range, accuracy, detection and quantitation limits, were statistically validated. The methods were successfully applied for the determination of Tenofovir and Emtricitabine on combined tablet formulations. The Linearity was performed in the range of 5 μg/ml to 30 μg/ml for Tenofovir at two wavelengths 296nm and 271nm and for Emtricitabine in the range of 2 μg/ml to 20 μg/ml at 271nm and 296 nm. The coefficient of correlation was found to be less than 0.990 at both wavelengths. Precision and recovery studies also found to be within the range. Hence the suggested simultaneous equation Spectroscopic method can be used for routine analysis of Emtricitabine and Tenofovir in API and Pharmaceutical dosage form.

Keywords: UV Spectrophotometry, Emtricitabine, Tenofovir, simultaneous equation method, validation.