A sustainable UPLC-UV method for quantification of donepezil hydrochloride in biorelevant media applied to dissolution profile comparison

Abstract

Donepezil hydrochloride is one of the most prescribed anti-Alzheimer’s drugs, despite being available for more than two decades, chromatographic methods for the quantification of the drug in biorelevant media that mimics pH physiological conditions in vivo (pH 1.2, 4.5, and 6.8) are not available in the literature. These media are used in the dissolution test, an important tool, for registration and quality control of medicines. Considering the need for methods with this purpose, this work aimed to develop and validate a sustainable UPLC-UV method for quantification of donepezil hydrochloride in tablets, specifically on assay and dissolution profile, with reduced environmental impacts. The proposed method has a run time of 2 min and requires for each run, only 0.8 mL of solvents, providing excellent green analysis. The method proved to be selective, linear, precise, accurate, robust in the range of 2–14 µg/mL. Three products (reference, similar, and generic) were analyzed and showed very rapid dissolution. The average content varied from 100.2 ± 0.6% to 109.5 ± 2.1%. Using dissolution efficiency (DE), the drug release profiles were compared in different biorelevant media.

Keywords:

• Donepezil hydrochloride
• ultra-performance liquid chromatography
• biorelevant media
• method development
• green analytical method
• dissolution profile

Disclosure statement

The authors report no conflict of interest.

Additional information

Funding

The authors would like to thank for financial support the Coordination for the Improvement of Higher Education Personnel (CAPES), Finance Code 001, the National Council for Scientific and Technological Development (CNPq), the Federal University of Ouro Preto (UFOP), and the Minas Gerais Research Foundation (FAPEMIG).