Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University, Assiut Branch, Assiut, 71524, Egypt.
Department of Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia, 61519, Egypt.
Luminescence. 2021 May;36(3):588-594. doi: 10.1002/bio.3976. Epub 2020 Nov 24.
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 λ 386 nm or λ 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 . 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.
在目前提出的分析中，设计了一种新的、可行的、选择性的荧光测定法来测定巴氯芬。巴氯芬是一种用于治疗多发性硬化症或脊髓损伤等疾病引起的肌肉痉挛的药物，以及打嗝等其他情况。该分析方法依赖于使用茚三酮形成荧光衍生物，在 λ 386nm 或 λ 480nm 处监测。在合适的反应条件下，巴氯芬中的伯氨基与茚三酮和苯乙酮在 Teorel 缓冲液作为缓冲介质的存在下缩合。当巴氯芬浓度与响应在 1-10μg/ml 的范围内作图时，该方法表现出线性。根据 ICH 指令正确地进行了反应变量的调整和验证参数的研究。进行了干扰研究以确保没有与赋形剂发生偏差。最后，该方法成功地应用于制剂中巴氯芬的测定，并扩展到测试 Mylobac 的含量均匀度。
