Dabigatran Etexilate Mesylate Lab Report

A simple, rapid, specific and highly sensitive spectrofluorimetric method has been developed for the quantification of dabigatran etexilate mesylate (DAB) in bulk and capsule dosage form. A linear relationship was found between fluorescence intensity and DAB concentration in the range of 0.01-1.0 μg/ml in DMSO as solvent at an emission wavelength of 391 nm after excitation at 334 nm, with a good correlation coefficient (0.989). The detection and quantification limits were found to be 0.005 and 0.015 µg/ml, respectively. The proposed method was applied for DAB capsules, results reveal with percentage recovery of 102% and percentage RSD values were found to be less than 2 for accuracy and precision studies. The proposed method was validated for linearity, range, accuracy, precision, limit of detection and quantification according to ICH guidelines. Statistical analysis of the results revealed high accuracy and good precision. The suggested procedures could be used for the determination of DAB in bulk and capsule dosage form in quality control laboratories of industries as well as in academic institutions.
Key words: Dabigatran etexilate
Capsules were emptied and weight of granules was calculated by subtracting weight of each empty shell from each capsule weight. Average weight was determined and an accurately weighed quantity of granules equivalent to 10 mg of DAB was transferred into 10 ml volumetric flask and dissolved in 5 ml of DMSO and sonicated for 10 minutes. Then the volume is made up to mark with the DMSO and filtered through whatmen filter paper. Further the filtrate was diluted with DMSO to get final concentrations within linearity range for quantification of DAB. Results were in good agreement with the label claim of the drug and reported in Table 2. The proposed method validated according to ICH guidelines