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

IF 4.3 2区 化学 Q2 CHEMISTRY, MULTIDISCIPLINARY
Mahmoud Abdelgaleel, Dalia M. Nagi, Mohamed Oraby, Sayed M. Derayea, Pakinaz Y. Khashaba
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引用次数: 0

Abstract

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.

应用亲核取代反应灵敏测定药物中的盐酸庚胺醇
通过药物与 5-二甲基氨基萘-1-磺酰氯(丹酰氯)的衍生化反应,建立了一种测定盐酸庚胺醇(HTM-HCl)的简单灵敏的光谱荧光测定法。试剂的氯原子与 HTM 发生亲核取代反应,生成 N-(5-二甲基氨基萘-1-磺酰基)-6-氨基-2-甲基庚-2-醇。用二氯甲烷萃取这种高发光衍生物,并在 345 nm 的激发波长和 490 nm 的发射波长下进行分析。化学反应发生在 pH 值为 10.5 的 0.1 M 硼酸盐缓冲溶液缓冲的水环境中。实验结果表明,该方法在 0.03 至 2 µg mL- 1 的浓度范围内具有灵敏度和线性关系。该方法的检出限和定量限分别为 0.016 和 0.048 µg mL- 1。该方法的分析验证遵循了国际协调理事会(ICH)的指导方针。该方法可有效地定量检测市售片剂和口服滴剂中的药物含量,片剂的回收率为 98.95 ± 0.45,口服滴剂的回收率为 99.37 ± 0.24,且无辅料干扰。
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来源期刊
BMC Chemistry
BMC Chemistry Chemistry-General Chemistry
CiteScore
5.30
自引率
2.20%
发文量
92
审稿时长
27 weeks
期刊介绍: BMC Chemistry, formerly known as Chemistry Central Journal, is now part of the BMC series journals family. Chemistry Central Journal has served the chemistry community as a trusted open access resource for more than 10 years – and we are delighted to announce the next step on its journey. In January 2019 the journal has been renamed BMC Chemistry and now strengthens the BMC series footprint in the physical sciences by publishing quality articles and by pushing the boundaries of open chemistry.
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