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稳定性指示荧光光度法,灵敏度高,用于测定药物中的盐酸万古霉素和人血浆中的加标样品:应用于降解动力学。

Stability-indicating spectrofluorimetric method with enhanced sensitivity for determination of vancomycin hydrochloride in pharmaceuticals and spiked human plasma: Application to degradation kinetics.

机构信息

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

Department of Agro-Environmental Sciences, Graduate School of Bioresource and Bioenvironmental Sciences, Kyushu University, Fukuoka 812-8581, Japan.

出版信息

J Food Drug Anal. 2018 Apr;26(2):834-841. doi: 10.1016/j.jfda.2017.06.005. Epub 2017 Jul 8.

Abstract

Based on investigating the relative fluorescence intensity of vancomycin hydrochloride (VCM) in methanol, a simple, highly sensitive, time-saving and specific spectrofluorimetric method was developed and validated. VCM fluorescence was measured at 335 nm when excited at 268 nm. Excellent linearity is obeyed in the concentration range 1-100 ng/mL with a detection limit of 5.94 pg/mL, a quantitation limit of 18.03 pg/mL and a very good correlation coefficient (r = 0.9999). Our method was applied to analyze VCM in pharmaceuticals as well as spiked human plasma. Moreover, VCM stability was studied when exposed to various degradation conditions such as oxidative, alkaline as well as acidic stress. Acidic and alkaline degradation kinetics of VCM was studied for the first time. The degradation follows pseudo-first-order kinetics. The apparent rate constants and half-life times were calculated. The Arrhenius equation was assessed and the activation energies of the degradation were also calculated. The developed method can be easily applied in quality control laboratories due to its sensitivity, specificity, simplicity and low cost.

摘要

基于对盐酸万古霉素(VCM)在甲醇中相对荧光强度的研究,建立并验证了一种简单、灵敏、省时且具有特异性的荧光光谱法。在 268nm 激发下,于 335nm 处测量 VCM 荧光。在 1-100ng/mL 的浓度范围内,线性良好,检测限为 5.94pg/mL,定量限为 18.03pg/mL,相关系数(r)非常好(r=0.9999)。该方法用于分析药物中的 VCM 以及加标人血浆中的 VCM。此外,还研究了 VCM 在各种降解条件下(如氧化、碱性和酸性应激)的稳定性。首次研究了 VCM 的酸性和碱性降解动力学。降解遵循准一级动力学。计算了表观速率常数和半衰期。评估了阿仑尼乌斯方程,并计算了降解的活化能。由于该方法具有灵敏度高、特异性强、简单、成本低等优点,可方便地应用于质量控制实验室。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e388/9322213/9b753a8f9e01/jfda-26-02-834f1.jpg

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