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高效环保的卡利拉嗪分光荧光测定法:一种分析和绿色化学方法。

Efficient and environmentally friendly spectrofluorimetric determination of cariprazine: An analytical and green chemistry approach.

机构信息

Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, Taif, Saudi Arabia.

Addiction and Neuroscience Research Unit, Health Science Campus, Taif University, Taif, Saudi Arabia.

出版信息

Luminescence. 2024 Aug;39(8):e4861. doi: 10.1002/bio.4861.

Abstract

Cariprazine represents a new generation of antipsychotic medication, characterized by its heightened affinity for the D3 receptor. It has recently obtained approval as an adjunctive treatment option for patients diagnosed with major depressive disorder. In this study, a novel approach utilizing fluorescence spectroscopy was developed to analyze cariprazine. The methodology involves the transformation of cariprazine into a fluorescent compound by means of chemical derivatization with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl). Following excitation at 470 nm, the fluorescent derivative displayed peak fluorescence emission at 550 nm. The factors influencing the derivatization process were optimized. Upon reaching the optimal reaction conditions, a linear correlation (r = 0.9995) was observed between the fluorescence intensity and concentrations of cariprazine ranging from 20 to 400 ng/ml. Detection and quantitation limits were determined to be 5.85 and 17.74 ng/ml, respectively. The approach was accurate and precise, with percent recovery values ranging from 98.14% to 99.91% and relative standard deviations of less than 2%. Application of the method to the analysis of cariprazine in bulk and commercial capsules forms yielded accurate results. Moreover, adherence to environmentally friendly analytical practices was evident through alignment with the principles of green analysis, as demonstrated by the analytical eco-scale, AGREE, and GAPI greenness assessment tools.

摘要

卡利拉嗪是一种新型抗精神病药物,其特点是对 D3 受体具有更高的亲和力。它最近已被批准作为辅助治疗重度抑郁症患者的选择。在这项研究中,采用荧光光谱法开发了一种分析卡利拉嗪的新方法。该方法通过用 4-氯-7-硝基苯并-2-氧代-1,3-二唑(NBD-Cl)进行化学衍生化将卡利拉嗪转化为荧光化合物。在 470nm 激发后,荧光衍生物在 550nm 处显示出峰值荧光发射。优化了影响衍生化过程的因素。在达到最佳反应条件后,观察到荧光强度与卡利拉嗪浓度在 20 至 400ng/ml 范围内呈线性相关(r=0.9995)。检测限和定量限分别为 5.85 和 17.74ng/ml。该方法准确、精密,回收率值在 98.14%至 99.91%之间,相对标准偏差小于 2%。该方法应用于对卡利拉嗪原料药和市售胶囊形式的分析,结果准确。此外,通过与绿色分析原则保持一致,即通过分析生态规模、AGREE 和 GAPI 绿色评估工具,证明该方法符合环保分析实践。

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