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一种经过验证的用于定量测定实验室制备的盐酸多奈哌齐和姜黄素共配制纳米脂质体中盐酸多奈哌齐和姜黄素的高效液相色谱-二极管阵列检测法的绿色度、蓝度和白度评估。

Assessment of greenness, blueness, and whiteness profiles of a validated HPLC-DAD method for quantitation of Donepezil HCl and Curcumin in their laboratory prepared co-formulated nanoliposomes.

作者信息

Abd Elwahab Mennah M, Saad Samar, Sheribah Zeinab A, El-Enany Nahed

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Sinai University - Arish branch, Arish, 45511, Egypt.

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, 35516, Egypt.

出版信息

BMC Chem. 2025 Jan 18;19(1):17. doi: 10.1186/s13065-024-01377-y.

Abstract

White and Green Analytical Chemistry are innovative approaches in analytical chemistry that prioritize both sustainability and efficiency. Together, these approaches aim to advance scientific research while minimizing environmental impact and enhancing safety. This integration of environmental consciousness into analytical practices represents a significant step forward in achieving sustainable scientific progress. In the present study, a sensitive eco-friendly HPLC-DAD method was carried out and validated to allow concurrent determination of Donepezil HCl (DPZ) and Curcumin (CUR) in their pure form and laboratory made nano-liposome formulation. Optimum seperation was accomplished by utilising Zobrax Eclipse Plus C18 column (4.6*100 mm,5 μm) with gradient elution of the mobile phase composed of 0.02 M phosphate buffer at pH 3.2 and ethanol at flow rate of 1.5 ml/min. A diode array detector (DAD) was implemented for detection at 273 nm and 435 nm for DPZ and CUR, respectively, with the column oven set at 40 °C. The method was validated according to ICH specifications in terms of accuracy, precision, linearity range, detection and quantification limit. The calibration plots were linear with correlation coefficients (r2) = 0.999 over the range (0.1-100 µg/ml) and (0.1-100 µg/ml) for DPZ and CUR, successively. The validated HPLC-DAD approach was adopted to analyse both medications in laboratory prepared nano-liposomal formulation in which the analytes were successfully quantified with good recovery values and no disrubtion from the added excipients. The investigation of whiteness, blueness, and greenness metrics revealed a major benefit of the suggested approach over previous reported ones.

摘要

白色和绿色分析化学是分析化学中的创新方法,它们将可持续性和效率放在首位。这些方法共同旨在推进科学研究,同时将环境影响降至最低并提高安全性。将环境意识融入分析实践代表了在实现可持续科学进步方面向前迈出的重要一步。在本研究中,开展并验证了一种灵敏的环保型高效液相色谱 - 二极管阵列检测法(HPLC - DAD),用于同时测定盐酸多奈哌齐(DPZ)和姜黄素(CUR)的纯品形式以及实验室制备的纳米脂质体制剂。使用Zobrax Eclipse Plus C18柱(4.6×100 mm,5 µm),以pH 3.2的0.02 M磷酸盐缓冲液和乙醇作为流动相进行梯度洗脱,流速为1.5 ml/min,实现了最佳分离。采用二极管阵列检测器(DAD)分别在273 nm和435 nm处对DPZ和CUR进行检测,柱温箱设置为40°C。该方法根据国际协调会议(ICH)规范在准确性、精密度、线性范围、检测限和定量限方面进行了验证。校准曲线在DPZ和CUR的范围(0.1 - 100 µg/ml)和(0.1 - 100 µg/ml)内呈线性,相关系数(r2)分别为0.999。采用经过验证的HPLC - DAD方法对实验室制备的纳米脂质体制剂中的两种药物进行分析,其中分析物成功定量,回收率良好,且未受到添加辅料的干扰。对白度、蓝度和绿度指标的研究表明,所建议的方法比先前报道的方法具有主要优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f7b/11743032/a25104e849d8/13065_2024_1377_Fig1_HTML.jpg

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