Abstract
ANA LYTICAL METHOD DEVELOPMENT AND VALIDATION OF DONEPEZIL HCL IN TABLET DOSAGE FORM BY UV SPECTROSCOPIC METHOD

A. Navya Sri, R. Sampath Kumar, S. Vinuthna, Md. Imran, Santhosh Illendula*, Ch. V. Suresh and K. N. V. Rao

ABSTRACT

A new simple, accurate, rapid, precise, reproducible and cost-effective spectrophotometric method for the quantitative estimation of Donepezil Hcl in tablet dosage form. The developed UV spectrophotometric method for the quantitative estimation of Donepezil Hcl is based on measurement of absorption at maxima wavelength 316nm using Ethanol. The standard and sample solution were prepared by using Ethanol as a solvent. Quantitative determination of the drug was performed at wavelength range nm. The linearity was established over the concentration range 5, 10, 15, 20, 25, μg/ml for the Donepezi Hcl with correlation coefficient value of 1 Precision studies showed that 1% relative standard deviation was within range of acceptable limits. The mean percentage recovery was found to be 98.6%. The proposed method has been validated as per ICH guidelines.

Keywords: Donepezil Hcl, UV spectrophotometer, Method development, Validation, Accuracy, Precision.


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