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.