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用于测定米多君片剂形式的简单超灵敏荧光光谱法:在含量均匀度测试中的应用。

Simple ultrasensitive spectrofluorimetric method for determination of midodrine in its tablet form: Application to content uniformity testing.

作者信息

Omar Mahmoud A, Nagy Dalia M, Halim Monica E

机构信息

Department of Pharmacognosy and Pharmaceutical Chemistry, College of Pharmacy, Taibah University, Medinah, Saudi Arabia.

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

出版信息

Luminescence. 2019 Dec;34(8):854-858. doi: 10.1002/bio.3682. Epub 2019 Jul 23.

DOI:10.1002/bio.3682
PMID:31338979
Abstract

A novel, simple, sensitive method was developed for determining midodrine spectrofluorimetrically in both its raw pure form and its tablet form. This study is based on the native fluorescence of midodrine and discusses the optimum solvent used and the wavelength range. The presented method was then validated with respect to linearity, accuracy, precision, and limits of detection and quantitation. The constructed calibration curve showed a linear range of 0.1-2.0 μg/ml. The limit of detection and limit of quantitation values were 0.03 and 0.10 μg/ml respectively. Finally, content uniformity testing was applied according to the United States Pharmacopoeia by adapting the presented method.

摘要

开发了一种新颖、简单、灵敏的方法,用于分光荧光法测定米多君的原料药及其片剂。本研究基于米多君的固有荧光,讨论了所用的最佳溶剂和波长范围。然后对所提出的方法进行了线性、准确度、精密度以及检测限和定量限方面的验证。构建的校准曲线显示线性范围为0.1 - 2.0μg/ml。检测限和定量限分别为0.03和0.10μg/ml。最后,根据美国药典采用所提出的方法进行含量均匀度测试。

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引用本文的文献

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Facile Integration of Hanztsch's Switch-Off/On Modeled Fluorogenic Probe for Feasible Tagging and Tracking of the Midodrine Drug in Different Matrices; First Evaluation of the Method's Greenness, Whiteness, Blueness, Quantum Yield, and Tablets' Content Homogeneity.汉茨希开关关闭/开启型荧光探针的简便集成,用于在不同基质中对米多君药物进行可行的标记和追踪;该方法的绿色度、白度、蓝度、量子产率及片剂含量均匀性的首次评估
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