ABSTRACT

The aim of this study was to verify the ability of the UV spectrophotometric method for the simultaneous determination of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form using the principal Component Regression (pCR) and partial Least Squares (pLS) multivariate calibration methods. Double beam UV-Vis spectrophotometer (Jasco V-730) with 1 cm quartz cell with 1 nm data interval and scanning speed of 400 nm min -1 was used in the study. the optimized wavelength range selected was 225-275 nm. the data obtained was processed using Unscrambler X (10.5) (64bit) software. The developed models showed good results over the concentration range of 6-36 μg mL -1 for tenofovir disoproxil fumarate and 4-24 μg mL-1 for emtricitabine with co-relation coefficient greater than 0.995 and % RSD less than 2%. the accuracy studies show % recovery within limits. The method was validated as per ICH Q2(R1) guideline.