测定原料和外用制剂中反式查尔酮含量的简单快速分光光度法

Renata M. Martinez, Nathalia Yurika Fukuda, Jenifer Freitas da Silva, Clara Ruiz de Souza, S. Georgetti, M. Baracat, R. Casagrande
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引用次数: 0

摘要

反式查尔酮(TC)是一种类黄酮前体,具有抗炎和抗氧化作用,作用范围广泛。然而,在官方药典中还没有用于分析这种物质的有效方法。因此,本研究旨在开发并验证一种简单、快速、可重复的分光光度法,用于分析原料和含有 TC 的外用药物制剂中的 TC。建立的条件为:提取溶剂为甲醇,紫外分光光度计的检测波长为 309 nm。所有检测均遵循2017年RDC 166号决议的规定。所提议的方法具有选择性。在 1 至 8 μg/mL 浓度范围内呈线性关系(r = 0.999)。TC 的相对标准偏差分别为 1.53% 和 2.70%,含有 TC 的制剂的相对标准偏差分别为 1.73% 和 2.91%,这证实了该方法的重复性和中等精密度。通过回收率测试评估的准确度很高,回收率最低为 98.24%,最高为 100.23%。据观察,故意进行的小修改并没有干扰结果,这表明该方法是可靠的。结果表明,该方法符合预期目的,成本低廉,易于应用,选择性好,线性,精确,准确,稳健,适用于 TC 和含 TC 药物制剂的测定。因此,所开发的方法满足了对测定 TC 和含 TC 的外用制剂的分析方法的需求,该方法有效、创新,有助于医药领域的发展。
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A simple and rapid spectrophotometric method for the determination of trans-chalcone in raw-material and topical formulation
Trans-chalcone (TC) is a flavonoid precursor characterized by a wide spectrum of action, with anti-inflammatory and antioxidant effects. However, no validated methods are available in official compendia for the analysis of this substance. Thus, the aim of this work was to develop and validate a simple, fast, and reproducible spectrophotometric method for the analysis of TC in raw material, and in topical pharmaceutical formulation containing TC. The established conditions were: methanol as extracting solvent, and detection wavelength of 309 nm by UV spectrophotometer. All tests followed the rules of Resolution RDC 166, 2017. The proposed method was selective. Linearity was demonstrated in the concentration range of 1 to 8 μg/mL (r = 0.999). Repeatability and intermediate precision were confirmed by low relative standard deviation values of 1.53% and 2.70% for TC, and of 1.73% and 2.91% for formulation containing TC. Accuracy, evaluated through recovery test, was adequate, with minimum of 98.24% and maximum of 100.23% of recovery. It was observed that the small deliberate modifications done did not interfere with the results, demonstrating the method is robust. The results showed that the method was considered suitable for the intended purpose, inexpensive, easy to apply, selective, linear, precise, accurate, and robust for the determination TC, and pharmaceutical formulation containing TC. Thus, the method developed satisfies the need for an analytical method for the determination of TC, and topical formulation containing TC, being effective, innovative and able to aid in the development of the pharmaceutical field.
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