Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.
Luminescence. 2024 Sep;39(9):e4887. doi: 10.1002/bio.4887.
A relevant approach based on the attractive inherited merits of fluorescence spectroscopy has been established for quantitative estimation of a newly approved second-generation atypical antipsychotic lurasidone (LUR) in its raw materials and pharmaceutical dosage forms. This study brings to light the strong native fluorescence of LUR at 400 nm in water after excitation at 316 nm. Different experimental parameters that may compromise the fluorescence of the drug were carefully investigated and optimized. A linear response was established between the relative fluorescence intensity and concentration over the concentration range of 50-650 ng/mL with excellent correlation (r = 0.9998). The validity of the method was evidenced in accordance with International Council for Harmonization guidelines, with minimal detection and quantification limits of 2.88 and 8.73 ng/mL, respectively. The method was effectively applied for the estimation of LUR in spiked human plasma and urine samples with acceptable recoveries. The biopharmaceutical significance of the method was heightened by its successful applications for both content uniformity and in vitro dissolution testing. Three different tools accredited the greenness character of the presented study. Eco-friendliness, effortlessness, and cost effectiveness are crucial hallmarks of our study. The presented study demonstrates potential applicability in quality control laboratories with limited resources.
基于荧光光谱法的诱人固有优势,建立了一种相关方法,用于对新批准的第二代非典型抗精神病药鲁拉西酮(LUR)在其原料药和药物制剂中的定量估计。本研究揭示了在 316nm 激发下,LUR 在水中于 400nm 处具有很强的固有荧光。仔细研究并优化了可能影响药物荧光的不同实验参数。在 50-650ng/mL 的浓度范围内,相对荧光强度与浓度之间建立了线性响应,相关性良好(r=0.9998)。该方法符合国际协调理事会指南的有效性要求,最小检测限和定量限分别为 2.88 和 8.73ng/mL。该方法有效地应用于人血浆和尿液样品中 LUR 的测定,回收率可接受。该方法成功应用于含量均匀度和体外溶出度测试,提高了其生物制药意义。三种不同的工具认可了本研究的绿色特性。环保、轻松和经济高效是我们研究的关键标志。本研究表明,对于资源有限的质量控制实验室具有潜在的适用性。