Prajapati Pintu, Shrivastav Shivangi, Shah Pranav, Surana Vilas, Kanasara Yashwini, Haque Anzarul, Shah Shailesh
Department of Quality Assurance & Department of Pharmaceutics, Maliba Pharmacy College, Uka Tarsadia University, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat, 394 350, Gujarat, India.
Central Laboratories Unit, Qatar University, Doha, 2713, Qatar.
J Fluoresc. 2025 Aug 16. doi: 10.1007/s10895-025-04518-1.
This study proposes a sensitive and green spectrofluorimetric method for assessing brucine in solid dispersion adsorbate formulations and spiked plasma samples by combining quality by design principles with white analytical chemistry concepts. This method attains nanogram-level sensitivity by employing fluorescein as a biosensing probe through photoinduced electron transfer. The targeted formulation showed improved solubility and dissolution rates compared with those of pure brucine. In-vivo pharmacokinetic studies revealed enhanced oral bioavailability with the BRU-SDA formulation achieving a significantly higher plasma concentration than the values obtained for the physical mixture. The proposed spectrofluorimetric technique was validated and showed good linearity, accuracy, and precision across a broad range of concentrations at nanoscale levels. The Lowest Limit of Detection (LOD) and Lowest Limit of Quantitation (LOQ) were found to be 10 and 20 ng•mL respectively, with recovery rates of 90-95% from biological samples. The method's overall performance was evaluated using the RGB12 principles, achieving exceptional scores of 95 for redness (analytical quality), 76 for greenness (environmental sustainability), and 100 for blueness (practical utility), resulting in an outstanding whiteness score of 90.33 out of 100. This comprehensive assessment demonstrates that the proposed method outperforms current chromatographic methods in terms of analytical performance, environmental sustainability, and practical usability. While maintaining equivalent sensitivity, this spectrofluorimetric technique proved to be more time-efficient, user-friendly, and less expensive than the published techniques. These benefits position the proposed method as a viable alternative for standard analysis in pharmaceutical quality control and research environments, representing a significant step towards more sustainable and effective analytical techniques in the pharmaceutical industry.
本研究提出了一种灵敏且绿色的荧光光谱法，通过将设计质量原则与白色分析化学概念相结合，用于评估固体分散吸附剂制剂和加标血浆样品中的马钱子碱。该方法通过光致电子转移，以荧光素作为生物传感探针，实现了纳克级的灵敏度。与纯马钱子碱相比，目标制剂的溶解度和溶出速率有所提高。体内药代动力学研究表明，BRU-SDA制剂的口服生物利用度提高，血浆浓度显著高于物理混合物。所提出的荧光光谱技术经过验证，在纳米级浓度范围内具有良好的线性、准确性和精密度。最低检测限（LOD）和最低定量限（LOQ）分别为10和20 ng•mL，生物样品的回收率为90-95%。使用RGB12原则对该方法的整体性能进行评估，红色度（分析质量）得分为95，绿色度（环境可持续性）得分为76，蓝色度（实际效用）得分为100，白色度得分为90.33（满分100）。这一综合评估表明，所提出的方法在分析性能、环境可持续性和实际可用性方面优于目前的色谱方法。在保持同等灵敏度的同时，这种荧光光谱技术被证明比已发表的技术更省时、用户友好且成本更低。这些优势使所提出的方法成为制药质量控制和研究环境中标准分析的可行替代方法，代表了制药行业朝着更可持续、更有效的分析技术迈出的重要一步。
