{"title":"分光光度法测定芬尼酮剂型和原料药的含量及验证","authors":"Husnain Fathima, Mahboob Pasha, Mohamed Khaleel","doi":"10.52711/0974-4150.2023.00033","DOIUrl":null,"url":null,"abstract":"A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Finerenone in pure drug and tablet dosage form. The absorbance was measured at 239.8nm using Ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml with coefficient of correlation (r2) of 0.997. Limit of detection (LOD) was found to be 1.220µg/ml and Limit of quantitation (LOQ) was found to be 5.220µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.","PeriodicalId":8550,"journal":{"name":"Asian Journal of Research in Chemistry","volume":"25 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Estimation and Validation of Finerenone in Dosage Form and in Bulk Drug by Spectrophotometric Method\",\"authors\":\"Husnain Fathima, Mahboob Pasha, Mohamed Khaleel\",\"doi\":\"10.52711/0974-4150.2023.00033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Finerenone in pure drug and tablet dosage form. The absorbance was measured at 239.8nm using Ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml with coefficient of correlation (r2) of 0.997. Limit of detection (LOD) was found to be 1.220µg/ml and Limit of quantitation (LOQ) was found to be 5.220µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.\",\"PeriodicalId\":8550,\"journal\":{\"name\":\"Asian Journal of Research in Chemistry\",\"volume\":\"25 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-06-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Asian Journal of Research in Chemistry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.52711/0974-4150.2023.00033\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Asian Journal of Research in Chemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.52711/0974-4150.2023.00033","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Estimation and Validation of Finerenone in Dosage Form and in Bulk Drug by Spectrophotometric Method
A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Finerenone in pure drug and tablet dosage form. The absorbance was measured at 239.8nm using Ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml with coefficient of correlation (r2) of 0.997. Limit of detection (LOD) was found to be 1.220µg/ml and Limit of quantitation (LOQ) was found to be 5.220µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.
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