紫外分光光度法测定原料药和纳米凝胶制剂中姜黄素含量的研究:水解降解研究

M. Rahman
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引用次数: 0

摘要

本研究的主要目的是建立并验证一种具有成本效益的紫外分光光度法测定原料药和纳米凝胶制剂中姜黄素的方法。根据国际协调会议(ICH)的指导方针对该方法进行了验证。发现姜黄素可溶于甲醇,λmax为425 nm。姜黄素浓度水平在(1 ~ 8µg mL)以上时,浓度与吸光度呈线性关系。回归方程为y = 0.1137x - 0.0138, R值为0.999。检测限和定量限分别为0.23 μ m和0.75 μ m。所分析样品的相对标准偏差小于2%,结果准确、精密度高、重复性好、稳健性好。理论浓度和测量浓度之间没有统计学上的显著差异。游离姜黄素(k = 0.042µg mL.h、0.53µg mL.h和0.068µg mL.h)和纳米凝胶制剂(k = 0.178 h、0.003 h和0.005 h)的降解动力学分别为零和一级。结果表明,该方法在不受辅料干扰的情况下对姜黄素纳米凝胶配方进行了特异性评价。该方法具有成本效益,可用于姜黄素的常规质量控制分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development of UV spectrophotometric method for estimation of curcumin in bulk drug and nanogel formulation: A hydrolytic degradation studies
The main purpose of this research was to develop and validate a cost effective UV spectrophotometric method for determination of curcumin in bulk drug and nanogel formulation. The method was validated according to the guideline of International Conference on Harmonisation (ICH). The curcumin was found to be soluble in methanol with λmax of 425 nm. Curcumin over the concentration level of (1-8 µg mL) depicted linear relation in the plot of concentration vs. absorbance. The regression equation of graph was y = 0.1137x - 0.0138 with R value of 0.999. The limits of detection and quantification were 0.23 μg mLand 0.75 μg mL, respectively. The method was accurate, precise, reproducible and robust since all the samples analyzed had relative standard deviation less than 2%. No statistically significant difference between theoretical and measured concentrations was detected. The degradation kinetics of free curcumin (k = 0.042 µg mL.h, 0.53 µg mL.h and 0.068 µg mL.h) and nanogel formulation (k = 0.178 h, 0.003 h and 0.005 h) were zero and first order, respectively. The proposed method was found to be specific while estimating curcumin loaded nanogel formulation without interference of excipients. The developed method was cost effective and can be used for routine quality control analysis of curcumin.
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