Quality by Design assisted the Ultraviolet Spectroscopic Method Development of Donepezil hydrochloride in Bulk and Dosage form

Background and Objectives: A novel ultraviolet spectroscopic method was developed and validated for the drug Donepezil Hydrochloride using the latest Quality by Design software as per (ICH) guidelines. This modern scientific technology has been implemented to study the impact of independent factors affecting the resultant absorbance of the drug and the selection of the solvent. Methods: A new method was developed by ultraviolet spectroscopy and the developed method was validated by using different validation parameters. Results: Donepezil showed maximum absorbance at 250 nm in methanol. The concentration range for linearity was detected in the range of 60-100μg/ml. The accuracy was found to be in the range of 98-100%. The chemical behavior of the drug and drug product was indicated by conducting forced degradation studies. The LOD and LOQ were determined as 2.507 μg/ml and 7.599 μg/ml. Conclusion: The results indicate that the QbD-assisted UV spectroscopic method for donepezil hydrochloride was simple, accurate, and precise. Therefore, it is suitable for routine analysis in quality control tests.