Prajapati Pintu, Mandal Pallavi, Solanki Hiral, Pulusu Veerashakar, Haque Anzarul, Ahmad Sarfaraz, Shah Shailesh
Department of Quality Assurance, Maliba Pharmacy College & Dr Chunibhai Vallabhbhai Patel College of Pharmacy, Uka Tarsadia University, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, 394 350, Surat, Gujarat, India.
Department of Chemistry and Biochemistry, Ohio University, Athens, OH, 47501, USA.
J Fluoresc. 2025 Aug 16. doi: 10.1007/s10895-025-04514-5.
This study introduces an innovative spectrofluorimetric method for determining fimasartan, a pharmaceutical compound, at low concentrations in drug formulations and human blood samples. The method incorporates several key features that enhance its effectiveness and sustainability. It utilizes eco-friendly solvents (water and ethanol) and reduces analysis time, making it both cost-effective and environmentally friendly. The integration of Quality by Design (QbD) principles ensures consistent quality throughout the analytical process. The method employs a microwave-assisted Hantzsch reaction for derivatization, which modifies the compound for improved detection. To optimize critical variables, the Placket-Burman design, a statistical tool, was implemented. The method demonstrates high performance with linearity in the range of 50-250 ng/mL, a Limit of Detection (LOD) of 10 ng/mL, and a Limit of Quantification (LOQ) of 50 ng/mL. It achieves excellent accuracy, with 99.61-100.58% recovery in pharmaceutical formulations and 91.67-94.94% in human plasma. The rapid analysis time of 30 s for derivatization further enhances its efficiency. Mass spectrometry confirmation verified the formation of a fluorescent Mannich base product. Notably, this method outperforms existing LC-MS and HPLC techniques based on RGB12, AGREE, and modified-GAPI assessments, demonstrating superior environmental performance. By successfully combining analytical quality, environmental sustainability, and cost-effectiveness, this new spectrofluorimetric method presents a valuable tool for researchers and pharmaceutical professionals in the analysis of fimasartan. Its ability to provide accurate measurements at very small nano-scale concentrations while maintaining eco-friendly practices makes it a significant advancement in pharmaceutical analysis techniques.
本研究介绍了一种创新的荧光光谱法，用于测定药物制剂和人体血液样本中低浓度的药物化合物非马沙坦。该方法具有几个关键特性，可提高其有效性和可持续性。它使用环保型溶剂（水和乙醇）并缩短分析时间，使其既经济高效又环保。设计质量（QbD）原则的整合确保了整个分析过程的质量一致性。该方法采用微波辅助的汉茨希反应进行衍生化，对化合物进行修饰以改善检测效果。为了优化关键变量，采用了统计工具普拉凯特-伯曼设计。该方法表现出高性能，线性范围为50-250 ng/mL，检测限（LOD）为10 ng/mL，定量限（LOQ）为50 ng/mL。它具有出色的准确度，在药物制剂中的回收率为99.61-100.58%，在人体血浆中的回收率为91.67-94.94%。衍生化的快速分析时间为30秒，进一步提高了其效率。质谱确证验证了荧光曼尼希碱产物的形成。值得注意的是，基于RGB12、AGREE和改良GAPI评估，该方法优于现有的LC-MS和HPLC技术，展现出卓越的环境性能。通过成功结合分析质量、环境可持续性和成本效益，这种新的荧光光谱法为研究人员和制药专业人员在非马沙坦分析中提供了一种有价值的工具。它能够在非常小的纳摩尔浓度下提供准确测量，同时保持环保做法，使其成为药物分析技术的一项重大进步。
