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两种绿色荧光分光光度法用于测定纯品盐酸托莫西汀及市售胶囊,并应用于含量均匀度检测。

Two green spectrofluorimetric methods for the assay of atomoxetine hydrochloride in pure form and commercial capsules with application to content uniformity testing.

作者信息

Barakat Neamat T, El-Brashy Amina M, Fathy Mona E

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.

出版信息

R Soc Open Sci. 2023 Apr 5;10(4):230010. doi: 10.1098/rsos.230010. eCollection 2023 Apr.

Abstract

Atomoxetine hydrochloride (ATX) is a potent and non-stimulant drug which was approved for the treatment of attention-deficit hyperactivity disorder. Owing to its importance, two green, simple and validated spectrofluorimetric methods were developed for its sensitive assay in pure and capsule forms. The first method (Method I) relied on measuring the enhanced fluorescence of ATX by the use of sodium dodecyl sulfate in alkaline medium at 227 nm/ 298 nm. The second method (Method II) involved complex formation of ATX with Erythrosine B (EB) in aqueous acidic solution resulting in quantitative quenching of the EB naive fluorescence. This complex was formed in the presence of Britton-Robinson buffer (pH 4.0). The difference in fluorescence intensity was measured at 527/ 550 nm. The calibration curves were linear through the ranges of 0.2-2.0 µg ml for Method I, 0.2-4.0 µg ml for Method II with good correlation coefficient ( = 0.9998) for both methods. The suggested methods were perfectly applied for determination of ATX in its commercial capsules and content uniformity test. The greenness of the proposed methods was confirmed by three different assessment tools and it was found that both methods were green, eco-friendly and environmentally safe.

摘要

盐酸托莫西汀(ATX)是一种强效非兴奋剂药物,已被批准用于治疗注意力缺陷多动障碍。鉴于其重要性,开发了两种绿色、简便且经过验证的荧光分光光度法,用于灵敏测定其纯品和胶囊剂型。第一种方法(方法I)依靠在碱性介质中使用十二烷基硫酸钠,于227nm/298nm处测量ATX增强后的荧光。第二种方法(方法II)涉及在酸性水溶液中ATX与赤藓红B(EB)形成络合物,导致EB天然荧光发生定量猝灭。该络合物在 Britton-Robinson 缓冲液(pH 4.0)存在下形成。在527/550nm处测量荧光强度差异。方法I的校准曲线在0.2 - 2.0μg/ml范围内呈线性,方法II在0.2 - 4.0μg/ml范围内呈线性,两种方法的相关系数均良好(= 0.9998)。所建议的方法完美适用于其市售胶囊中ATX的测定及含量均匀度测试。通过三种不同的评估工具证实了所建议方法的绿色程度,发现这两种方法均绿色、环保且对环境安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6635/10073903/346c6c999ba0/rsos230010f01.jpg

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