Spectrofluorimetric Method Development and Validation of Doravirine and Tablet Formulation

A novel, easy, simple and economic Spectrofluorimetric method for the estimation of the antiviral drug doravirine was developed and validated. This work is focused for quantifying the bulk and formulation of doravirine using a simple spectrofluorimetric method which is more sensitive and has rapid response than that of time consuming HPLC methods and lower sensitivity uv-visible spectrophotometric methods. The spectrofluorometric method mainly depends on fluorescence of doravirine in a methanol after excitation at 315 nm gives an emission at 385 nm. The emission and excitation slit width was 5 nm with a scan speed of 60,000 nm/min. Doravirine showed a linearity in the concentration range of 20-60 µg/ml with detection limit and quantitation limit of 1.2968 μg/ml and 3.9297 μg/ml respectively. The regression equation y = 1238.6x-589 with correlation coefficient (r2) of 0.9995 was obtained. The fluorescence spectrum of the laboratory prepared doravirine tablet showed no interference with the excipients and the percent assay was found to be 100.31%. The proposed method was developed and validated according to ICH Q2(R1) guidelines. The percentage recovery was found to be in the range of 98.57% to 100.65%. For the estimation of doravirine in bulk and the tablet dosage form, a simple, accurate and cost-efficient spectrofluorimetric method has been developed.