托吡司他的平行多模紫外可见分光光度法研究

IF 1 4区 化学 Q4 SPECTROSCOPY
Pooja Barkule, Amod S. Patil, Atul A. Shirkhedkar, Saurabh B. Ganorkar, Suraj R. Chaudhari
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引用次数: 0

摘要

托吡司他(TPX)是一种用于治疗痛风的黄嘌呤氧化还原酶抑制剂。建立了四种简便、特异、精确、灵敏、快速、环保的紫外可见分光光度法测定原料药和片剂中TPX的方法。虽然紫外可见分光光度法的估计工作是基于零阶和一阶导数光谱变换,但这些方法也依赖于紫外光谱的吸光度、幅度和曲线下面积。TPX在2 ~ 12 μg/mL范围内呈线性关系,相关系数r2 >; 0.99。在开发的方法中估计的药物百分比被发现与托吡马克片剂配方的标签声明很好地一致。每种方法都按照国际协调委员会(ICH) Q2(R2)指南进行了验证。所有这些开发的方法都是线性的、准确的、精确的、足够敏感的,并使用单因素方差分析来评估结果的统计比较。分析表明,发现f值小于临界p值,并且在结果中没有可识别的可变性。这表明,四种方法的结果之间没有显著的统计学差异,表明它们是估计TPX的最佳并行和多模式方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Parallel and Multimode UV-Visible Spectrophotometry Investigations for Topiroxostat

Topiroxostat (TPX) is a xanthine oxidoreductase inhibitor used in the treatment of gout. For the determination of TPX in bulk and tablets, four simple, specific, precise, sensitive, rapid, and eco-friendly, parallel UV-Visible spectrophotometry methods were developed. Although UV-Visible spectrophotometry estimation work is based on zero-order and first-order derivative spectral transformation, these methods also relied on absorbance, amplitude, and area under the curve of the UV-spectrum. TPX exhibited linearity in the concentration range of 2–12 μg/mL in all four methods, with a correlation coefficient of r2 > 0.99. The estimated percentage of drug in the developed methods was found to be in good agreement with what the label claim for the Topimac® tablet formulation. Each method was validated in accordance with the International Council for Harmonisation (ICH) Q2(R2) guidelines. All of these developed methods were linear, accurate, precise, and adequately sensitive, and they were evaluated using one-way ANOVA to assess the statistical comparison of the results. The analyses indicated that the F-value was found to be less than the critical P-value, and there was no identifiable variability in the outcomes. This implied that, for all four methods, there were no significant statistical differences between the results, indicating that they are the best parallel and multimode approaches for the estimation of TPX.

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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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