Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Fayoum University, Egypt.
Department of Pharmacognosy and Pharmaceutical Chemistry, College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Saudi Arabia.
Luminescence. 2024 Sep;39(9):e4888. doi: 10.1002/bio.4888.
Mizolastine is an antihistamine drug that is commonly used for treatment of chronic urticaria and allergic rhinitis. In this study, a facile, rapid, and sustainable fluorimetric method was established for the estimation of mizolastine in pharmaceutical and biological matrices for the first time. The approach methodology relied on the direct assessment of mizolastine's intrinsic fluorescence at 313 nm after excitation at 272 nm. This intrinsic fluorescence, stemming from the benzimidazole fluorophore moiety in mizolastine structure, serves as a distinctive marker for its precise quantification in the spiked human plasma and pharmaceutical formulations with high %recovery. The method exhibits reasonable sensitivity with lower limits of detection and quantification of 5.4 and 16.6 ng mL, respectively, across a concentration range of 25.0-2000.0 and 50-1000 ng mL for the standard mizolastine analysis and mizolastine assay in the plasma sample, respectively. Moreover, the established method was applied to assess tablet content uniformity and mizolastine assay in plasma samples with high recoveries (98.50%-100.20%). Such applications underscore the method's potential applicability within quality control laboratories, preventing the need for sample preparation or laborious extraction steps. Finally, the method's sustainability and practicality were confirmed by applying different greenness and whiteness metrics, yielding excellent results.
米唑斯汀是一种抗组胺药物，常用于治疗慢性荨麻疹和过敏性鼻炎。在这项研究中，首次建立了一种简便、快速和可持续的荧光法，用于评估药物和生物基质中的米唑斯汀。该方法依赖于在 272nm 激发下直接评估米唑斯汀的固有荧光，在 313nm 处。这种固有荧光源于米唑斯汀结构中的苯并咪唑荧光团部分，是其在人血浆和药物制剂中精确定量的独特标记，具有高回收率。该方法具有合理的灵敏度，检测限和定量限分别为 5.4 和 16.6ng·mL，在 25.0-2000.0ng·mL 浓度范围内，用于标准米唑斯汀分析和血浆样品中的米唑斯汀测定。此外，该方法还用于评估片剂的含量均匀度和血浆样品中的米唑斯汀测定，回收率高（98.50%-100.20%）。这些应用突出了该方法在质量控制实验室中的潜在适用性，避免了样品制备或繁琐提取步骤的需要。最后，通过应用不同的绿色度和白度指标，证实了该方法的可持续性和实用性，结果非常出色。
