Darolutamide is an oral nonsteroidal androgen receptor antagonist used to delay the process of prostate cancer to metastatic disease and to increase the quality of life for people with advanced prostate cancer. Here, a second spectrofluorimetric method was advanced for quantifying Darolutamide in pharmaceutical formulation and spiked human plasma. This method depends on the fluorescence derivatization of Darolutamide with 4‐chloro‐7‐nitrobenzo‐2‐oxa‐1,3‐diazole (NBD‐Cl) at 75°C in a (pH 9) of borate buffer to produce a fluorescent derivative that can be detected at 520 nm after excitation at 460 nm. The method has been validated using ICH criteria, and it demonstrated linearity in the range 5–200 ng ml−1. The limit of detection (LOD) and limit of quantitation (LOQ) were 1.15 and 3.84 nm, respectively. The proposed method was applied precisely and accurately for quantifying Darolutamide within the pharmaceutical formulation and spiking human plasma without any interferences. Moreover, the method's sustainability was evaluated and compared with the published method using two greenness assessment tools termed analytical eco‐scale and Analytical GREEnness (AGREE). These findings suggest that the method is more sustainable than the published method.

中文翻译：

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利用绿色化学可持续荧光衍生化方法对药物制剂和加标人血浆中作为抗肿瘤药物的达洛鲁胺进行荧光定量

Darolutamide 是一种口服非甾体雄激素受体拮抗剂，用于延缓前列腺癌转移性疾病的进程，并提高晚期前列腺癌患者的生活质量。这里，提出了第二种荧光分光光度法，用于定量药物制剂和加标人血浆中的达洛鲁胺。该方法依赖于 Darolutamide 与 4-氯-7-硝基苯并-2-氧杂-1,3-二唑 (NBD-Cl) 在 75°C 下在硼酸盐缓冲液 (pH 9) 中进行荧光衍生化，产生荧光衍生物在 460 nm 激发后可在 520 nm 处检测到。该方法已使用 ICH 标准进行验证，并在 5-200 ng ml 范围内表现出线性−1。检测限 (LOD) 和定量限 (LOQ) 分别为 1.15 和 3.84 nm。所提出的方法被精确地应用于定量药物制剂中的达洛鲁胺并加标人血浆，没有任何干扰。此外，使用两种绿色度评估工具（称为分析生态规模和分析绿色度（AGREE））对该方法的可持续性进行了评估，并与已发布的方法进行了比较。这些发现表明该方法比已发表的方法更具可持续性。