Department of Pharmacy and Pharmaceutical Sciences, Federal University of Ouro Preto, Ouro Preto, Brazil.
Federal Institute of Minas Gerais, Ouro Preto, Brazil.
Drug Dev Ind Pharm. 2020 Oct;46(10):1578-1588. doi: 10.1080/03639045.2020.1810266. Epub 2020 Aug 31.
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 (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.
盐酸多奈哌齐是最常被开处的抗老年痴呆症药物之一，尽管它已经问世超过 20 年，但在模拟生理 pH 条件（pH 1.2、4.5 和 6.8）的生物相关介质中定量测定该药物的色谱方法在文献中尚未见报道。这些介质用于溶出度测试，这是药品注册和质量控制的重要工具。鉴于对此类方法的需求，本工作旨在开发和验证一种可持续的 UPLC-UV 方法，用于定量测定片剂中的盐酸多奈哌齐，特别是在测定和溶出度方面，同时减少对环境的影响。该方法的运行时间为 2 分钟，每次运行仅需 0.8 mL 溶剂，具有出色的绿色分析特性。该方法被证明具有选择性、线性、精密度、准确度，在 2-14 µg/mL 范围内表现良好。对三种产品（参比、相似和通用）进行了分析，结果显示其具有非常快速的溶出度。平均含量在 100.2 ± 0.6%至 109.5 ± 2.1%之间变化。使用溶出度效率（DE）比较了不同生物相关介质中的药物释放曲线。
