紫外光谱法测定原料药和制剂中伏立康唑含量的建立与验证

IF 0.8 4区 化学 Q4 SPECTROSCOPY
Pranita Sunil Kanojiya, Rita Naresh Wadetwar
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引用次数: 0

摘要

本工作旨在建立一种简便的紫外分光光度法测定伏立康唑的分析方法,并对其进行验证。选择甲醇和pH为4.1的人工阴道液(AVF)作为溶剂建立分析方法,并在不同的参数下对方法进行验证。伏立康唑在甲醇溶液和AVF溶液中均表现出较高的256 nm吸光度。根据国际协调会议(ICH)指南对分析参数的线性度、精密度和准确度进行了研究。在10 ~ 50 μg/mL浓度范围内,甲醇与AVF pH 4.1呈线性关系,且符合Beer定律,相关系数分别为0.998和0.999。结果表明,准确度和重复性参数均在98 ~ 102%范围内,具有较高的置信区间。灵敏度方面,该药物在甲醇和AVF pH 4.1中的检出限分别为2.55和2.00 μg/mL。该药物在甲醇中检出限为7.75 μg/mL,在AVF pH 4.1中检出限为6.08 μg/mL。该方法简单、可靠、经济、省时。该方法可进一步用于计算载药纳米结构脂质载体的包封效率和片剂药物含量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of Ultraviolet Spectroscopic Method for Estimation of Voriconazole in Bulk and Pharmaceutical Formulation

The present work aimed to develop a simple analytical method and validate the same for the estimation of Voriconazole using ultraviolet spectrophotometry. Methanol and artificial vaginal fluid (AVF) pH 4.1 were chosen as solvents for the development of the analytical method and the validation of the method was done for the different parameters. Voriconazole showed higher absorbance at 256 nm both in methanol and AVF pH 4.1. Linearity, precision, and accuracy as the analytical parameters were studied as per the International Conference of Harmonization (ICH) guidelines. The concentration range of 10–50 μg/mL in methanol and AVF pH 4.1 showed a linear response and followed Beer's law with coefficient correlation values of 0.998 for methanol and 0.999 for AVF pH 4.1. The results for the accuracy and the repeatability parameter presented values that lie within the range of 98–102%, indicating a higher confidence interval. Regarding the method's sensitivity, the LOD for the drug in methanol and AVF pH 4.1 was found to be 2.55 and 2.00 μg/mL, respectively. The LOQ for the drug in methanol was 7.75 μg/mL and in AVF pH 4.1 was 6.08 μg/mL. The proposed, developed and validated method was simple, sturdy, cost-effective, and time-saving. The method could be further applied to calculate the entrapment efficiency of the drug-loaded nanostructured lipid carrier and tablet drug content.

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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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