关键词: content uniformity testing erythrosine B fluorescence quenching greenness evaluation lurasidone

Mesh : Lurasidone Hydrochloride / chemistry analysis Erythrosine / chemistry Spectrometry, Fluorescence Static Electricity Hydrogen-Ion Concentration Tablets / analysis Antipsychotic Agents / chemistry Fluorescent Dyes / chemistry Limit of Detection

来  源:   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-1 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:
最近开发的抗精神病药物,Lurasidone,是用一个简单的,敏感,和生态友好的荧光光谱法。所建议的方法是基于鲁拉西酮在使用Teorell-Stenhagen缓冲液(pH4)的酸性环境中对赤藓红B的固有荧光的可量化猝灭影响。在530nm激发后,在552nm监测赤藓红B荧光的猝灭。系统变量进行了系统优化,以增强鲁拉西酮-赤藓红B离子对的形成,用于分析目的。在20-600ngmL-1的范围内建立线性校准图,相关系数为0.9998。定量和检测限为13.5和4.5ng/mL,分别。根据国际协调理事会(ICH)指导原则评估了设计方法的分析有效性。所提出的方法具有很高的回收率,用于评估散装粉末及其治疗片剂剂型中的鲁拉西酮。此外,使用开发的方法测试片剂制剂的均匀性。最后,使用各种工具评估了既定方法的绿色性。
公众号