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建立并验证用于测定纳米脂质体和血浆中姜黄素的荧光分光光度法。

Spectrofluorometric Method Development and Validation for the Determination of Curcumin in Nanoliposomes and Plasma.

机构信息

Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Department of Pharmaceutical Nanotechnology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

J Fluoresc. 2020 Sep;30(5):1113-1119. doi: 10.1007/s10895-020-02574-3. Epub 2020 Jul 8.

DOI:10.1007/s10895-020-02574-3
PMID:32643044
Abstract

In this paper, we have reported a rapid, simple, sensitive, straightforward, and validated method for the concentration determination of curcumin (CUR) in nanoliposomes and plasma using the spectrofluorimetry. For both nanoliposomal formulation and plasma, methanol was used as a solvent to extract the CUR. The excitation and emission wavelengths were set at 423 nm and 527 nm, respectively. The method validation was performed based on International Council for Harmonization (ICH) guidelines, Q2, in which parameters; such as, linearity, precision, accuracy and etc., were determined. The results showed that the calibration curve was linear for CUR concentrations of 0.05 to 0.5 μg /mL with a correlation coefficient of 0.9996. The limit of detection (LOD) and limit of quantification (LOQ) were 0.03 and 0.10 μg/mL, respectively. Liposomal CUR (15 mg/kg) was injected intravenously to mice, and at certain time intervals (1, 3, 6, and 24 h), blood samples were collected. The samples were extracted by methanol and CUR concentrations were detected using a fluorescence spectrophotometer. Results indicated the rate of liposomal formulation decline was slower than free CUR. The results of this study indicated that the validation method based on fluorimetry which was developed here is reliable for the detection of CUR in liposomal formulations and plasma.

摘要

本文报道了一种快速、简单、灵敏、直接且经过验证的荧光分光光度法,用于纳米脂质体和血浆中姜黄素(CUR)浓度的测定。对于纳米脂质体制剂和血浆,均使用甲醇作为溶剂来提取 CUR。激发和发射波长分别设置为 423nm 和 527nm。方法验证基于国际人用药品注册技术协调会(ICH)指南 Q2 进行,其中确定了线性、精密度、准确度等参数。结果表明,CUR 浓度在 0.05 至 0.5μg/mL 范围内呈线性,相关系数为 0.9996。检测限(LOD)和定量限(LOQ)分别为 0.03 和 0.10μg/mL。将 15mg/kg 的脂质体 CUR 静脉注射到小鼠体内,在特定时间间隔(1、3、6 和 24h)采集血样。用甲醇提取样品,并用荧光分光光度计检测 CUR 浓度。结果表明,脂质体制剂的下降速度比游离 CUR 慢。本研究结果表明,这里建立的荧光光度法验证方法可用于检测脂质体制剂和血浆中的 CUR。

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