Study of Anticoagulant Dabigatran by Analytical Instrumentation

Dabigatran with IUPAC name 3-({2-[(4-Carbamimidoyl-phenylamino)-methyl]-1-methyl-1H-benzoimidazole-5-carbonyl}-pyridin-2-yl-amino)-propionic acid, which can be used to prevent strokes in those with atrial fibrillation due to causes other than heart valve disease, and at least one additional risk factor for stroke (congestive heart failure, hypertension, age, diabetes, and prior stroke), with molecular formula C34H41N7H5 was studied in detail for functional group analysis with FTIR, characteristic absorbance by UV-NIR, thermal behavior by TGA-DTA-DSC, particle size and stability of the molecule with Nano particle size analyzer. The structure was confirmed by LC-MS/MS with ESI probe and mass was found in aggregation with the reported standard values. The purity of drug was determined by Prep. HPLC analysis. FTIR analysis showed the characteristic peak of carboxylic acid, UV-NIR analysis showed that the λmax was 224 nm with methanol as a diluent, the compound was found stable in the thermal analysis, the average particle size was found to be 25.2 nm, Z-average as 0.2 nm and zeta potential as -67.6 mv hence showed excellent stability in the zeta potential analysis as per ASTM standards D4187-82, American Society of Testing and Materials, 1985.