Pharmaceutical Analysis Department, Faculty of Pharmacy, Damanhour University, Damanhour, 22511, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Egypt.
Sci Rep. 2023 Aug 29;13(1):14131. doi: 10.1038/s41598-023-40946-4.
Nitazoxanide (NTX) is an antimicrobial drug that was used for the treatment of various protozoa. However, during the coronavirus pandemic, NTX has been redirected for the treatment of such virus that primarily infect the respiratory tract system. NTX is now used as a broad-spectrum antiviral agent. In this study, a highly sensitive and green spectrofluorometric method was developed to detect NTX in various dosage forms and its metabolite, tizoxanide (TX), in human plasma samples using nitrogen and sulfur co-doped carbon quantum dots nanosensors (C-dots). A simple and eco-friendly hydrothermal method was used to synthetize water soluble C-dots from citric acid and l-cysteine. After excitation at 345 nm, the luminescence intensity was measured at 416 nm. Quenching of C-dots luminescence occurred upon the addition of NTX and was proportional to NTX concentration. Assessment of the quenching mechanism was performed to prove that inner filter effect is the underlying molecular mechanism of NTX quenching accomplished. After optimizing all experimental parameters, the analytical procedure was evaluated and validated using the ICH guidelines. The method linearity, detection and quantification limits of NTX were 15 × 10-15.00 µg/mL, 56.00 × 10 and 15 × 10 µg/mL, respectively. The proposed method was applied for the determination of NTX in its commercial pharmaceutical products; Nanazoxid oral suspension and tablets. The obtained % recovery, relative standard deviation and % relative error were satisfactory. Comparison with other reported spectrofluorimetric methods revealed the superior sensitivity of the proposed method. Such high sensitivity permitted the selective determination of TX, the main metabolite of NTX, in human plasma samples making this study the first spectrofluorimetric method in literature that determine TX in human plasma samples. Moreover, the method greenness was assessed using both Eco-Scale and AGREE approaches to prove the superiority of the proposed method greenness over other previously published spectrofluorimetric methods for the analysis of NTX and its metabolite, TX, in various dosage forms and in human plasma samples.
硝唑尼特（NTX）是一种抗菌药物，曾用于治疗各种原生动物。然而，在冠状病毒大流行期间，NTX 被重新用于治疗主要感染呼吸道系统的此类病毒。NTX 现在被用作广谱抗病毒药物。在这项研究中，开发了一种高灵敏度和绿色的光谱荧光法，使用氮和硫共掺杂的碳量子点纳米传感器（C-dots）在各种剂型的 NTX 和其代谢物替硝唑（TX）在人血浆样品中进行检测。使用简单且环保的水热法，从柠檬酸和 L-半胱氨酸合成水溶性 C-dots。在 345nm 激发后，在 416nm 处测量发光强度。当加入 NTX 时，C-dots 的发光会猝灭，并且与 NTX 浓度成正比。评估猝灭机制以证明内滤效应是 NTX 猝灭的潜在分子机制。在优化所有实验参数后，根据 ICH 指南评估和验证分析程序。NTX 的方法线性度、检测限和定量限分别为 15×10-15.00μg/mL、56.00×10 和 15×10μg/mL。该方法已应用于其商业药物制剂中硝唑尼特的测定；纳米佐氟沙星口服液和片剂。获得的回收率、相对标准偏差和相对误差%均令人满意。与其他报道的光谱荧光法相比，该方法具有更高的灵敏度。这种高灵敏度允许选择性地测定 TX，即 NTX 的主要代谢物，在人血浆样品中，这使得该研究成为文献中第一个用于测定人血浆样品中 TX 的光谱荧光法。此外，还使用生态标度和 AGREE 方法评估了该方法的绿色度，以证明与其他先前发表的用于分析各种剂型和人血浆样品中的 NTX 及其代谢物 TX 的光谱荧光法相比，该方法的绿色度具有优越性。
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