Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：EltrombopagOlamine是一种用于治疗血小板减少症的药物，一种血小板计数降低和严重再生障碍性贫血的疾病。它作为血小板生成素受体激动剂，在骨髓中产生血小板。
目的：本研究的目的是开发一种简单的，具体,准确,精确而经济的紫外光谱法估算EltrombopagOlamine在散装和片剂剂型中的含量。
方法：开发的方法使用甲醇进行，用于药物的鉴定和理化表征。验证参数，如线性，精度,准确度,检测和定量的鲁棒性极限，和特异性根据ICHQ2（R2）进行评估。
结果：在甲醇中发现药物的最大吸收波长（λmax）为247nm。在2-14μg/ml浓度范围内呈线性关系，回归方程y=0.0619x-0.0123，r²=0.999。使用标准加入法来确定所开发方法的准确性。发现结果在98-99%的%回收率范围内。精度是在λmax上相对于参数，如重复性，盘中,和隔天。发现该方法是精确的,因为发现%RSD值<2%。检测限值(LOD)和定量限值(LOQ)分别为0.0524μg/ml和0.1588μg/ml,分别。
结论：开发的方法简单，经济,准确和选择性。所开发的方法适用于药物剂型和常规质量控制实验室中EltrombopagOlamine分析的评估。
目的：本研究的目的是开发一种简单的，具体,准确,精确而经济的紫外光谱法估算EltrombopagOlamine在散装和片剂剂型中的含量。
方法：开发的方法使用甲醇进行，用于药物的鉴定和理化表征。验证参数，如线性，精度,准确度,检测和定量的鲁棒性极限，和特异性根据ICHQ2（R2）进行评估。
结果：在甲醇中发现药物的最大吸收波长（λmax）为247nm。在2-14μg/ml浓度范围内呈线性关系，回归方程y=0.0619x-0.0123，r²=0.999。使用标准加入法来确定所开发方法的准确性。发现结果在98-99%的%回收率范围内。精度是在λmax上相对于参数，如重复性，盘中,和隔天。发现该方法是精确的,因为发现%RSD值<2%。检测限值(LOD)和定量限值(LOQ)分别为0.0524μg/ml和0.1588μg/ml,分别。
结论：开发的方法简单，经济,准确和选择性。所开发的方法适用于药物剂型和常规质量控制实验室中EltrombopagOlamine分析的评估。
