Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
Spectrochim Acta A Mol Biomol Spectrosc. 2024 Jan 15;305:123458. doi: 10.1016/j.saa.2023.123458. Epub 2023 Sep 26.
This study describes the enhancement of the weak native fluorescence of loratadine (LOR) by dual strategy via photoinduced electron transfer (PET) blocking followed by micellization into sodium dodecyl sulfate micelles. The enhanced fluorescence was employed as a basis for the development of a novel microwell spectrofluorimetric assay (MW-SFA) for the determination of LOR in its pharmaceutical dosage forms and urine samples. The assay was conducted in 96-microwell assay plates, and the enhanced fluorescence signals were measured by a microplate reader at 290 and 435 nm for excitation and emission, respectively. The optimum conditions of the assay were established, calibration curve was generated, and the linear regression equation was computed. The relation between the fluorescence signals and LOR concentrations was linear with good determination coefficients (0.9992) in the range of 10 - 2000 ng mL. The assay limits of detection and quantitation were 4.1 and 12.5 ng mL, respectively. The precision was satisfactory, with values of relative standard deviation not exceeding 1.68%, and the assay's accuracy was ≥ 99.1%. The proposed was successfully applied to the analysis of LOR in its pharmaceutical dosage forms with acceptable accuracy and precision. The label claims were 99.3 - 100.5% (±0.95 - 1.59%). Statistical analysis comparing the results of the proposed assay with those obtained by a reported pre-validated assay revealed no significant difference between both methods in terms of the accuracy and precision at the 95% confidence level. The assay was also applied to the analysis of urine samples containing LOR with accuracy ≥ 98.24%. The greenness of the proposed assay was confirmed by three efficient metric tools. In overall conclusion, the proposed assay is characterized by high sensitivity, procedure simplicity, and high throughput, enabling the simultaneous analysis of many samples in a short time. Therefore, it is a valuable tool for rapid routine application in pharmaceutical quality control units and clinical laboratories for the determination of LOR.
本研究通过光诱导电子转移（PET）阻断 followed by 胶束化进入十二烷基硫酸钠胶束，描述了 loratadine（LOR）的弱天然荧光的增强。增强的荧光被用作开发新型微孔板荧光测定法（MW-SFA）的基础，用于测定其药物制剂和尿液样品中的 LOR。测定在 96 微孔板测定板中进行，通过微孔板读数器在 290 和 435nm 处分别测量增强的荧光信号进行激发和发射。建立了测定的最佳条件，生成了校准曲线，并计算了线性回归方程。荧光信号与 LOR 浓度之间的关系呈线性关系，在 10-2000ngmL 范围内具有良好的确定系数（0.9992）。测定的检出限和定量限分别为 4.1 和 12.5ngmL。精密度令人满意，相对标准偏差值不超过 1.68%，测定的准确度≥99.1%。该方法成功应用于 LOR 药物制剂的分析，具有可接受的准确度和精密度。标签声称值为 99.3-100.5%（±0.95-1.59%）。在 95%置信水平下，对两种方法的准确性和精密度进行统计分析，结果表明两种方法之间没有显著差异。该测定法还应用于含有 LOR 的尿液样品的分析，准确度≥98.24%。通过三种有效的度量工具证实了所提出的测定法的绿色性。总的来说，该测定法具有高灵敏度、简单的程序和高通量的特点，能够在短时间内同时分析许多样品。因此，它是一种用于快速常规应用于药物质量控制单位和临床实验室的有价值的工具，用于测定 LOR。
