Utility of dansyl chloride for the establishment of a sensitive spectrofluorimetric approach for estimating midodrine hydrochloride: application to content uniformity testing

Derayea, Sayed M.; Abdelgaleel, Mahmoud; Nagi, Dalia M.; Oraby, Mohamed; Khashaba, Pakinaz Y.

doi:10.1039/d3ra06268f

RSC Adv.

2023

DOI: 10.1039/d3ra06268f

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Utility of dansyl chloride for the establishment of a sensitive spectrofluorimetric approach for estimating midodrine hydrochloride: application to content uniformity testing

Sayed M. Derayea,

Mahmoud Abdelgaleel,

Dalia M. Nagi

et al.

Abstract: Midodrine interacts with dansyl chloride to yield a highly fluorescent product with a large Stokes shift. The reaction provided a highly sensitive spectrofluorimetric method for determining midodrine as well as testing content uniformity.

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2024

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Cited by 3 publications

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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

Hamad,

Saleh,

Mahdi

et al. 2024

J Fluoresc

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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

Hamad,

Saleh,

Mahdi

et al. 2024

J Fluoresc

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A Novel Spectrofluorimetric Method for Vibegron in the Newly FDA Approved Pharmaceutical Formulation and in Human Plasma: Analytical QbD Strategy for Method Development and Optimization

Wadie,

Tantawy,

Goda

2024

J Fluoresc

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Vibegron is a novel selective beta-3 adrenergic receptor agonist molecule, recently approved by US Food and Drug Administration (FDA) in tablet pharmaceutical formulation for treating overactive bladder syndrome. Such formulation necessitates the development of a simple, fast and cost-effective methodology capable of assaying the drug in various real samples with high sensitivity. Herein, a facile and robust spectrofluorimetric method was introduced, for the first time, for vibegron quantification based on analytical quality-by-design approach. The method involves drug reaction with dansyl chloride at pH 9.8, as a smart approach to overcome the non-fluorescent nature of vibegron, giving a highly fluorescent yellow derivative measured at 514 nm after being excited at 345 nm. Plausible reaction scheme between the drug and dansyl chloride was elucidated through studying the differences in their infrared (IR) spectra. Variables affecting fluorescence intensities were carefully screened and rationally optimized via preliminary scouting studies and central composite design for accurate and robust results. Full International Council for Harmonisation (ICH) validation protocol was followed where linearity was achieved in range of 20.0–400.0 ng/mL with minimum detectability of 3.6 ng/mL. The proposed method expressed good capability in assaying the marketed dosage forms with no excipient inference. Finally, the high sensitivity of such method paved the way for extending its application to quantify vibegron in spiked human plasma at concentrations around its real human plasma concentrations for further bioavailability studies.

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Application of nucleophilic substitution reaction for sensitive determination of heptaminol hydrochloride in pharmaceuticals

Abdelgaleel,

Nagi,

Oraby

et al. 2024

BMC Chemistry

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A straightforward and sensitive spectrofluorimetric approach was established for the determination of heptaminol hydrochloride (HTM-HCl) based on the derivatization of the drug through its reaction with 5-dimethylaminonaphthalene-1-sulfonyl chloride (Dansyl chloride). The reagent underwent a nucleophilic substitution of its chlorine atom with HTM to give N-(5-dimethylaminonaphthalene-1-sulfonyl)-6-amino-2-methylheptan-2-ol. The highly luminescent derivative was extracted using methylene chloride and subjected to analysis at an excitation wavelength of 345 nm and an emission wavelength of 490 nm. The chemical reaction occurred within an aqueous environment buffered with a 0.1 M borate buffer solution adjusted to pH 10.5. Experimental findings indicate that the proposed method displays sensitivity and linearity across a concentration range from 0.03 to 2 µg mL− 1. The method achieves lower detection and quantification limits of 0.016 and 0.048 µg mL− 1, respectively. The analytical validation of this method followed the guidelines outlined by the International Council of Harmonization (ICH). This approach was applied effectively for quantifying the medication in both tablet and oral drops formulations available on the market, demonstrating excellent recovery of 98.95 ± 0.45 for tablets and 99.37 ± 0.24 for oral drops with no interference from excipients.

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Utility of dansyl chloride for the establishment of a sensitive spectrofluorimetric approach for estimating midodrine hydrochloride: application to content uniformity testing

Abstract: Midodrine interacts with dansyl chloride to yield a highly fluorescent product with a large Stokes shift. The reaction provided a highly sensitive spectrofluorimetric method for determining midodrine as well as testing content uniformity.

Cited by 3 publications

References 23 publications

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

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

A Novel Spectrofluorimetric Method for Vibegron in the Newly FDA Approved Pharmaceutical Formulation and in Human Plasma: Analytical QbD Strategy for Method Development and Optimization

Application of nucleophilic substitution reaction for sensitive determination of heptaminol hydrochloride in pharmaceuticals

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