Gangu Sreelatha, S. Rg, T. Harshana, Y. D. Spandana, Y. A. Reddy
{"title":"建立和验证可见分光光度法测定散剂和片剂中艾曲波帕乙醇胺的含量","authors":"Gangu Sreelatha, S. Rg, T. Harshana, Y. D. Spandana, Y. A. Reddy","doi":"10.55218/jasr.202314808","DOIUrl":null,"url":null,"abstract":"A simple and sensitive visible spectrophotometric method has been developed for the quantitative estimation of Eltrombopag Olamine in its bulk and tablet dosage form. It is an orally active ethanolamine salt of Eltrombopag, a smallmolecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. The maximum absorbance of drug was found at 425nm. Eltrombopag Olamine was found to be dissolved in Methanol so it was used as solvent for the conduction of work. Linearity range for the method was finalized as 3-18 μg/ml with R2 value of 0.9995. % RSD less than 2 which is well within indicates the method is precise and robust. The % recovery rate was found to be 100-101% indicating the method’s accuracy. The method was validated as per ICH guidelines provided and the results were found to be satisfactory. LOD & LOQ values were obtained as 0.150 & 0.456 respectively. Stability studies shows that the drug is unstable in various stress conditions like acid, base, water and oxidation.","PeriodicalId":14906,"journal":{"name":"Journal of Advanced Scientific Research","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"DEVELOPMENT AND VALIDATION OF VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ELTROMBOPAG OLAMINE IN BULK AND TABLET DOSAGE FORM\",\"authors\":\"Gangu Sreelatha, S. Rg, T. Harshana, Y. D. Spandana, Y. A. Reddy\",\"doi\":\"10.55218/jasr.202314808\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A simple and sensitive visible spectrophotometric method has been developed for the quantitative estimation of Eltrombopag Olamine in its bulk and tablet dosage form. It is an orally active ethanolamine salt of Eltrombopag, a smallmolecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. The maximum absorbance of drug was found at 425nm. Eltrombopag Olamine was found to be dissolved in Methanol so it was used as solvent for the conduction of work. Linearity range for the method was finalized as 3-18 μg/ml with R2 value of 0.9995. % RSD less than 2 which is well within indicates the method is precise and robust. The % recovery rate was found to be 100-101% indicating the method’s accuracy. The method was validated as per ICH guidelines provided and the results were found to be satisfactory. LOD & LOQ values were obtained as 0.150 & 0.456 respectively. Stability studies shows that the drug is unstable in various stress conditions like acid, base, water and oxidation.\",\"PeriodicalId\":14906,\"journal\":{\"name\":\"Journal of Advanced Scientific Research\",\"volume\":\"1 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-10-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Advanced Scientific Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.55218/jasr.202314808\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Advanced Scientific Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.55218/jasr.202314808","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
DEVELOPMENT AND VALIDATION OF VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ELTROMBOPAG OLAMINE IN BULK AND TABLET DOSAGE FORM
A simple and sensitive visible spectrophotometric method has been developed for the quantitative estimation of Eltrombopag Olamine in its bulk and tablet dosage form. It is an orally active ethanolamine salt of Eltrombopag, a smallmolecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. The maximum absorbance of drug was found at 425nm. Eltrombopag Olamine was found to be dissolved in Methanol so it was used as solvent for the conduction of work. Linearity range for the method was finalized as 3-18 μg/ml with R2 value of 0.9995. % RSD less than 2 which is well within indicates the method is precise and robust. The % recovery rate was found to be 100-101% indicating the method’s accuracy. The method was validated as per ICH guidelines provided and the results were found to be satisfactory. LOD & LOQ values were obtained as 0.150 & 0.456 respectively. Stability studies shows that the drug is unstable in various stress conditions like acid, base, water and oxidation.