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A new feasible approach based on utility of ninhydrin for selective fluorimetric analysis of baclofen. Application to content uniformity evaluation
Luminescence ( IF 2.9 ) Pub Date : 2020-11-03 , DOI: 10.1002/bio.3976
Ahmed A Abu-Hassan 1 , Ramadan Ali 1 , Sayed M Derayea 2
Affiliation  

In the current proposed analysis, a new, feasible, and selective fluorimetric approach was designed for baclofen assay. Baclofen is a medication prescribed as a therapy for muscle spasticity that originated from multiple sclerosis or a spinal cord injury, and other cases such as hiccups. The analytical approach relies on the use of ninhydrin to form a fluorescent derivative that was monitored at λex 386 nm or λem 480 nm. Under suitable reaction conditions, the primary amino moiety in baclofen was condensed with ninhydrin and phenylacetaldehyde in the presence of Teorel buffer as a buffered medium. The method exhibited linearity when baclofen concentration was plotted against response in the range 1–10 μg ml−1. Adjustment of the reaction variables and study of validation parameters according to ICH directives were performed correctly. An interference study was implemented to ensure that no discrepancy from the excipient had occurred. Finally, the proposed method was applied successfully for baclofen assay in dosage form and extended to test Mylobac content uniformity.

中文翻译:

一种基于茚三酮效用的新可行方法,用于巴氯芬的选择性荧光分析。在内容一致性评估中的应用

在当前提出的分析中,设计了一种新的,可行的,选择性的荧光方法用于巴氯芬测定。巴氯芬是一种处方药,可作为治疗多发性硬化症或脊髓损伤以及其他情况(例如打h)引起的肌肉痉挛的药物。的分析方法依赖于使用茚三酮,以形成在λ监测荧光衍生物的386纳米或λ EM 480纳米。在合适的反应条件下,将巴氯芬中的伯氨基部分与茚三酮和苯乙醛在Teorel缓冲液作为缓冲介质存在下缩合。当绘制巴氯芬浓度相对于1–10μgml -1范围内的响应作图时,该方法表现出线性。正确执行了根据ICH指令进行的反应变量调整和验证参数的研究。进行干扰研究以确保与赋形剂之间没有差异。最终,该方法成功地应用于剂型的巴氯芬测定中,并扩展到检测Mylobac含量的均匀性。
更新日期:2020-11-03
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