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利用赤藓红 B 通过静电吸引作用作为卢拉西酮测定的荧光标记物;在含量均匀度测试中的应用。

Exploitation of erythrosine B as a fluorometric marker for lurasidone determination through electrostatic attraction; application to content uniformity test.

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Sohag University, Sohag, Egypt.

Department of Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia, Egypt.

出版信息

Luminescence. 2024 Jul;39(7):e4845. doi: 10.1002/bio.4845.

Abstract

A recently developed antipsychotic drug, lurasidone, was determined using a simple, sensitive, and eco-friendly spectrofluorimetric approach. The suggested approach was based on the quantifiable quenching impact of lurasidone on the inherent fluorescence of erythrosine B in an acidic environment employing a Teorell-Stenhagen buffer (pH 4). Following excitation at 530 nm, the quenching of erythrosine B fluorescence was monitored at 552 nm. The system variables were systematically optimized to enhance the formation of the lurasidone-erythrosine B ion pair for analytical purposes. A linear calibration graph was built in the range of 20-600 ng mL with 0.9998 as a coefficient of correlation. The quantitation and detection limits were 13.5 and 4.5 ng/mL, respectively. The analytical validity of the designed approach was assessed with respect to International Council on Harmonization (ICH) guiding principles. The proposed methodology was employed with high recoveries for assessing lurasidone in bulk powder and its therapeutic tablet dosage form. Additionally, the uniformity of tablet formulations was tested using the developed approach. Finally, the established approach was assessed for its greenness using various tools.

摘要

最近开发的一种抗精神病药物——鲁拉西酮,采用了一种简单、灵敏、环保的分光荧光法进行测定。该方法基于鲁拉西酮在酸性环境中定量猝灭 Erythrosine B 固有荧光的能力,使用 Teorell-Stenhagen 缓冲液(pH 4)。在 530nm 激发后,监测 552nm 处 Erythrosine B 荧光的猝灭。系统地优化了系统变量,以增强分析目的下鲁拉西酮- Erythrosine B 离子对的形成。建立了在 20-600ng mL 范围内具有 0.9998 相关系数的线性校准曲线。定量和检测限分别为 13.5 和 4.5ng/mL。所设计的方法的分析有效性已根据国际协调会议(ICH)指导原则进行了评估。该方法用于评估散装粉末和治疗片剂剂型中的鲁拉西酮,回收率高。此外,还使用所开发的方法测试了片剂制剂的均匀性。最后,使用各种工具评估了所建立方法的绿色度。

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