Abstract

Purpose: The main objective of present research work was to develop and validate the two UV-spectrophotometric methods for the simultaneous estimation of tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride in bulk and pharmaceutical dosage form. Methods: Method A is based on the simultaneous equation and method B on the multi-component analysis by using methanol: 0.1N HCl (7:3) as a solvent. The simultaneous equation method depends on mainly that among three components (tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride), each of which absorbs at the λmax of each other. The multi component method mainly based on the total absorbance of a solution at a given wavelength is equal to the sum of the absorbance of the individual component. Results: The λmax of tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride was found to be 259nm, 291 nm and 280 nm respectively. The linearity range of tenofovir disproxil fumarate, emtricitabine, and rilpivirine was between 3-21, 1-10 and 0.5-3 μg/ml respectively. The both methods were validated for various parameters as per ICH guidelines and the results were found to be in acceptable limits. Conclusion: New, simple, accurate spectrophotometric methods were developed for the simultaneous estimation of tenofovir disproxil fumarate, emtricitabine and rilpivirine.