A VALIDATED METHOD DEVELOPMENT FOR ESTIMATION OF BENDAMUSTINE HCL IN BULK AND SOLID DOSAGE FORM BY 1ST ORDER DERIVATIVE SPECTROSCOPY

摘要

? 2022 Indian Drug Manufacturers' Association. All rights reserved.This study aimed to expand the trouble-free, quick, cost-effective and sensitive 1st order derivative spectroscopy method for bendamustine hydrochloride.The aliquot was scanned from 200-400 nm using blank methanol as a solvent and the absorption was recorded. The stored spectrum was modified into the first derivative spectrum by using Uv probe software and the detection wavelength was selected as 269 nm in methanol. The linearity was considered more at the concentration range bearing 10-80 μg mL-1 with the regression equation established to be y = 0.001x+0.005 (R2=0.998).The % RSD for intra-day precision study was found to be 1.6043% and inter-day precision was found to be 1.3274%. System and method precision were determined to be less than 2%. LoD and LoQ were found to be 0.6435 μg and 1.9501 μg, respectively. The assay of the marketed formulations was found to be 99.78%. All of the validation parameters were found to be below 2% RSD. Hence, the method can be used for the estimation of bendamustine hydrochloride in bulk dosage forms and the method was validated as per ICH guidelines Q2(R1).