利用紫外光谱快速、简便、低成本地建立片剂中艾曲波帕乙醇胺的定量分析方法

Nandan Godani, Sanjay Sharma
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引用次数: 0

摘要

Eltrombopag Olamine 是一种用于治疗血小板减少症(一种血小板计数降低的疾病)和严重再生障碍性贫血的药物。本研究的目的是开发一种简单、特异、准确、精确和经济的紫外光谱法,用于估算 Eltrombopag Olamine 在散剂和片剂中的含量。根据 ICHQ2 (R2)对线性、精密度、准确度、稳健性、检出限和定量限以及特异性等验证参数进行了评估。在 2-14 μg/ml 浓度范围内呈线性关系,回归方程为 y = 0.0619x - 0.0123,r² = 0.999。采用标准添加法测定所开发方法的准确度。结果发现回收率在 98-99% 之间。对重复性、日内和日间等参数的 λmax 进行了精密度测定。发现该方法的 RSD 值小于 2%,因此该方法是精确的。该方法具有简便、经济、准确和选择性强等特点。该方法适用于药物剂型和实验室常规质量控制中艾曲波帕乙醇胺的分析。
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Rapid, Simple and Low-Cost Analytical Method Development for Quantification of Eltrombopag Olamine in Tablet dosage by UV Spectroscopy Method
Eltrombopag Olamine is a drug used to treat thrombocytopenia, a disorder where blood platelet counts get lower and severe aplastic anemia. It serves as a thrombopoietin receptor agonist, which give rise to platelet production in the bone marrow The objective of this study is to develop a simple, specific, accurate, precise and economical Ultraviolet spectroscopy method to estimate the amount of Eltrombopag Olamine in bulk and tablet dosage form. The developed method was performed using methanol for identification and physicochemical characterization of the drug. The validation parameters like linearity, precision, accuracy, robustness limits of detection and quantitation, and specificity were assessed as per ICH Q2 (R2). The maximum absorbance wavelength (λmax) of the drug was found at 247 nm in methanol. The linearity was found in the concentration range of 2-14 μg/ml with regression equation y = 0.0619x - 0.0123 and r² = 0.999. The standard addition method was used to determine the accuracy of the developed method. The result was found in the % recovery range of 98-99%. The precision was done on λmax with respect to the parameters such as repeatability, intraday, and interday. The method was found to be precise as the % RSD value was found to be <2%. The detection limit value (LOD) and quantitation limit value (LOQ) were 0.0524 µg/ml and 0.1588 µg/ml, respectively. The developed method is simple, economical, accurate and selective. The developed method was adaptable for the estimation of Eltrombopag Olamine analysis in pharmaceutical dosage form and routine quality control laboratory.
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