DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TENOFOVIR DISPROXIL FUMARATE AND EMTRICITABINE IN TABLET DOSAGE FORM BY DERIVATIVE SPECTROSCOPIC METHOD

A simple, accurate, precise, economical spectroscopic method was developed and validated for the quantification of Tenofovir Disoproxil Fumarate and Emtricitabine in combined dosage form. The method obeys Beer’s law in concentration ranges of 10-80 μg/mL with correlation coefficient of 0.998 for Tenofovir Disoproxil Fumarate and correlation coefficient of 0.997 for Emtricitabine respectively. The method was validated for linearity, accuracy, precision, LOD, LOQ and assay as per ICH guidelines. The zero crossing point for Tenofovir Disoproxil Fumarate and Emtricitabine was 240 and 280nm respectively in water. The LOD values were found to be 0.286 μg/mL and 0.392 μg/mL for Tenofovir Disoproxil Fumarate and Emtricitabine respectively. The LOQ values were found to be 0.869 μg/mL and 1.190 μg/mL for Tenofovir Disoproxil Fumarate and Emtricitabine respectively. The %RSD for intraday and interday precision were found to be less than 2%. Recovery by this method was found to be 99% for both the analytes. The assay results were found to be 98.4% for Tenofovir Disoproxil Fumarate and 97.5% for Emtricitabine respectively. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage forms.