紫外分光光度法测定双氯芬酸钠含量的建立与验证

Chaitali A. Yeola, Vaishali N. Sonawane, Vijayraj N. Sonawane, Khemchand R. Surana, Dhananjay M. Patil, Deepak D. Sonawane
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引用次数: 0

摘要

分析方法验证是证明或记录分析方法产生可用于其目的的数据的过程。分析过程的主要目标是得到可重复的、可信的、足以达到预期目的的结果。建立了一种简便有效的紫外可见光谱定量分析双氯芬酸钠的方法。以蒸馏水为溶剂,最大吸收峰(λmax)为275nm。整个研究采用λmax 275nm。线性范围为8 ~ 16 μg/ml,相关系数(r2)为0.9969。方法精密度高,RSD < 2%。研究发现,该溶液在4小时内保持稳定。根据ICH指南(Q2),建议的方法是准确和具体的。
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Development and Validation of Simple UV- Spectrophotometric Method for Estimation of Diclofenac Sodium
Analytical method validation is the process of proving or documenting that an analytical method produces data that can be used for what it was made for. The main goal of an analytical procedure is to get results that can be repeated and can be trusted and are good enough for the intended purpose. An effective and simple method was developed and validated for quantitative analysis of Diclofenac sodium by using UV Visible Spectroscopy. The absorption maxima (λmax) were found to be 275nm by using Distilled Water as Solvent. The λmax 275nm was used for the whole study. The linearity range was 8-16 μg/ml with a correlation coefficient (r2) of 0.9969. The method was precise and robust with a %RSD less than 2%. The solution was found to be stable up to 4 hours. The proposed method was accurate and specific as per ICH guidelines (Q2).
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