Development and validation of a spectrofluorimetric method for the estimation of Tenofovir in bulk and formulation

Abstract

A simple, accurate, precise, sensitive and cost-effective spectrofluorimetric method was developed and validated for the estimation of Tenofovir in bulk and formulation. The relative fluorescence intensity of Tenofovir was measured in Distilled Water: Methanol (40:60%v/v) at an excitation wavelength of 374 nm and an emission wavelength of 409 nm. Proposed method was found to be linear over the range of 50 to 1000 ng/ml with correlation coefficient 0.999. Proposed method was validated using different analytical method validation parameters viz. Accuracy, precision, LOD, LOQ, robustness and ruggedness using QC standards as per the ICH guidelines. The percentage recovery was found to be 100.29 % and percentage RSD values were found to be less than 2 for accuracy and precision studies. The detection and quantification limits for the proposed method were found to be 3.009ng/ml and 9.120ng/ml, respectively. A simple, accurate, precise, sensitive yet cost-effective spectrofluorimetric method was developed for the estimation of Tenofovir in bulk and formulation. The said spectrofluorimetric method was found to be economic as it comprises water as a solvent.