Mostafa Noha S, Ayish Nada S, Abdel Rahman Mona A
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., ET-11562 Cairo, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., ET-11562 Cairo, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2025 Feb 5;326:125168. doi: 10.1016/j.saa.2024.125168. Epub 2024 Sep 21.
Designing new verified methods for the determination of pharmaceutical compounds in their specified formulation without prior separation and with high sensitivity taking in consideration analytical performance and simplicity has become a major concern of pharmaceutical quality control units. In the present work, a new simple and eco-friendly spectrofluorimetric method was developed and validated for the determination of Naproxen (NAP) and Domperidone (DOM) in their binary mixture, pharmaceutical formulation in addition to human plasma without prior separation. The proposed method is based on measuring the second derivative fluorescence intensity for NAP at 345 nm and for DOM at 292 after excitation at 235 nm without any interference from each other. All the variables affecting fluorescence intensity were studied and optimized. The proposed method showed excellent sensitivity with limit of detection (LOD) 12.286 ng/mL and 3.240 ng/mL for NAP and DOM respectively. In compliance with the ICH requirements, the optimized method was validated and was successfully utilized for the determination of both drugs in their pharmaceutical formulation and human plasma. Finally, the greenness of the proposed method was assessed using different assessment tools.
设计无需预先分离且具有高灵敏度的新验证方法，用于测定特定制剂中的药物化合物，同时兼顾分析性能和简便性，已成为药品质量控制部门的主要关注点。在本工作中，开发并验证了一种新的简单且环保的荧光分光光度法，用于测定二元混合物、药物制剂以及人血浆中的萘普生（NAP）和多潘立酮（DOM），无需预先分离。所提出的方法基于在235nm激发后，测量NAP在345nm处和DOM在292nm处的二阶导数荧光强度，二者互不干扰。研究并优化了所有影响荧光强度的变量。所提出的方法具有出色的灵敏度，萘普生和多潘立酮的检测限（LOD）分别为12.286ng/mL和3.240ng/mL。按照国际人用药品注册技术协调会（ICH）的要求，对优化后的方法进行了验证，并成功用于测定药物制剂和人血浆中的两种药物。最后，使用不同的评估工具对所提出方法的绿色度进行了评估。
