Abstract：
This study introduces a practical and cost-effective method for tracking diltiazem (DLZ) analytically. It utilizes a fluorimetric approach that relies on the modulation of fluorescence intensity of a dye called erythrosine B. Through a one-pot experiment performed in an acidic environment, a complex is rapidly formed between DLZ and erythrosine B. By observing the decrease in erythrosine B emission, a linear calibration plot is established, enabling the detection and quantification of DLZ concentrations ranging from 40 to 850 ng/ml. The estimated limits of detection and quantitation were 10.5 and 32.1 ng/ml, respectively. The variables affecting the DLZ-dye complex system were carefully adjusted. The validity of the approach was confirmed through a thorough evaluation based on the criteria set by ICH guidelines. The accuracy and precision of the methodology were evaluated, and the standard deviation and relative standard deviation were below 2. The strategy was successfully employed to analyze DLZ in tablets and capsules, and no significant variation between the proposed and reported methods as the values of the estimated t-test and F-test at five determinations were below 2.306 and 6.338, respectively. Notably, the method adheres to the principle of green chemistry by utilizing distilled water as the dispersing medium.
摘要：
本研究介绍了一种实用且经济高效的分析跟踪地尔硫（DLZ）的方法。它采用了一种荧光方法，该方法依赖于一种称为赤色素B的染料的荧光强度的调制。通过在酸性环境中进行的一锅实验，DLZ和赤藓红B之间迅速形成复合物。通过观察赤藓红B发射的减少，建立了线性校准图，能够检测和定量40至850ng/ml的DLZ浓度。估计的检测和定量限为10.5和32.1ng/ml，分别。仔细调整影响DLZ-染料络合物体系的变量。该方法的有效性通过基于ICH指南设定的标准的全面评估得到证实。评估了该方法的准确性和精密度，标准偏差和相对标准偏差均低于2。该策略已成功用于分析片剂和胶囊中的DLZ，由于五次测定的t检验和F检验的估计值分别低于2.306和6.338，因此提出的方法与报告的方法之间没有显着差异。值得注意的是,该方法坚持绿色化学原理，以蒸馏水为分散介质。
