通过绿色方法开发和验证米拉贝琼的紫外可见分光光度法

IF 0.8 4区 化学 Q4 SPECTROSCOPY
Chirag H. Dhamal, Kanji D. Kachhot, Foram H. Vaghela, Hitendra S. Joshi
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引用次数: 0

摘要

利用紫外可见分光光度法对原始状态和药用片剂中的米拉贝琼进行定量测定,该方法具有创新性、精心设计、针对性强、快速、精确和成本效益高等特点。在对溶解性、稳定性、毒性和致癌性等因素进行充分考虑后,石油醚成为首选溶剂,符合环保方法的原则。在波长为 250 nm 处可以明确检测到最大吸收,因此石油醚成为首选溶剂。该方法在 0.004 至 0.016 mg/mL 的浓度范围内忠实地遵循比尔定律,相关系数高达 0.9945。根据数据集精心计算出的 LOD 和 LOQ 值分别为 0.0001663 和 0.0005039。根据数据集精心计算得出的相对标准偏差小于 2%。此外,在严格的准确性评估中,米拉贝琼的恢复率在 98.62% 到 101.46% 的狭窄范围内,令人印象深刻。在日内和日间精确度评估中,%Assay 始终保持在 99.63% 至 101.12% 的严格范围内,肯定了该方法的精确度。此外,在整个综合验证过程中,确保了严格遵守 ICH Q2 (R1) 中规定的准则,从而巩固了该方法在分析应用中的可信度和适用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
UV-Vis Spectrophotometric Method Development and Validation of Mirabegron Via Green Approach

An innovative, meticulously crafted, targeted, expeditious, precise, and cost-effective methodology was pioneered utilizing UV-Vis spectrophotometry for the quantitative determination of Mirabegron in both its pristine state and pharmaceutical tablet formulation. Following thorough deliberation on factors such as solubility, stability, toxicity, and carcinogenicity, petroleum ether emerged as the solvent of choice, aligning with the principles of environmentally conscious methodology. The absorption maxima were unequivocally detected at a wavelength of 250 nm, making petroleum ether the solvent of choice. The method adheres faithfully to Beer's law within a concentration range spanning from 0.004 to 0.016 mg/mL, boasting a remarkable correlation coefficient of 0.9945. LOD and LOQ were meticulously computed from the dataset, yielding values of 0.0001663 and 0.0005039, respectively. The relative standard deviation, meticulously derived from the dataset, stands at less than 2%. Moreover, in the rigorous accuracy assessment, Mirabegron's recovery percentage fell impressively within the narrow band of 98.62 to 101.46%. During both the intraday and interday precision evaluations, the %Assay remained consistently within the stringent range of 99.63 to 101.12%, affirming the method's precision. Furthermore, adherence to the rigorous guidelines outlined in ICH Q2 (R1) was ensured throughout the comprehensive validation process, consolidating the method's credibility and suitability for analytical applications.

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来源期刊
CiteScore
1.30
自引率
14.30%
发文量
145
审稿时长
2.5 months
期刊介绍: Journal of Applied Spectroscopy reports on many key applications of spectroscopy in chemistry, physics, metallurgy, and biology. An increasing number of papers focus on the theory of lasers, as well as the tremendous potential for the practical applications of lasers in numerous fields and industries.
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