{"title":"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","authors":"Nandan Godani, Sanjay Sharma","doi":"10.2174/0118723128289305240404070703","DOIUrl":null,"url":null,"abstract":"\n\nEltrombopag 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\n\n\n\nThe objective of this study is to develop a simple, specific, accurate, precise and\neconomical Ultraviolet spectroscopy method to estimate the amount of Eltrombopag Olamine in\nbulk and tablet dosage form.\n\n\n\nThe 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\nQ2 (R2).\n\n\n\nThe maximum absorbance wavelength (λmax) of the drug was found at 247 nm in\nmethanol. The linearity was found in the concentration range of 2-14 μg/ml with regression\nequation 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\n98-99%. The precision was done on λmax with respect to the parameters such as repeatability,\nintraday, and interday. The method was found to be precise as the % RSD value was found to be\n<2%. The detection limit value (LOD) and quantitation limit value (LOQ) were 0.0524 µg/ml\nand 0.1588 µg/ml, respectively.\n\n\n\nThe 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.\n","PeriodicalId":72844,"journal":{"name":"Drug metabolism and bioanalysis letters","volume":"25 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Rapid, Simple and Low-Cost Analytical Method Development for Quantification of Eltrombopag Olamine in Tablet dosage by UV Spectroscopy\\nMethod\",\"authors\":\"Nandan Godani, Sanjay Sharma\",\"doi\":\"10.2174/0118723128289305240404070703\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\\n\\nEltrombopag 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\\n\\n\\n\\nThe objective of this study is to develop a simple, specific, accurate, precise and\\neconomical Ultraviolet spectroscopy method to estimate the amount of Eltrombopag Olamine in\\nbulk and tablet dosage form.\\n\\n\\n\\nThe 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\\nQ2 (R2).\\n\\n\\n\\nThe maximum absorbance wavelength (λmax) of the drug was found at 247 nm in\\nmethanol. The linearity was found in the concentration range of 2-14 μg/ml with regression\\nequation 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\\n98-99%. The precision was done on λmax with respect to the parameters such as repeatability,\\nintraday, and interday. The method was found to be precise as the % RSD value was found to be\\n<2%. The detection limit value (LOD) and quantitation limit value (LOQ) were 0.0524 µg/ml\\nand 0.1588 µg/ml, respectively.\\n\\n\\n\\nThe 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.\\n\",\"PeriodicalId\":72844,\"journal\":{\"name\":\"Drug metabolism and bioanalysis letters\",\"volume\":\"25 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-04-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug metabolism and bioanalysis letters\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2174/0118723128289305240404070703\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug metabolism and bioanalysis letters","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/0118723128289305240404070703","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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.