{"title":"测定富马酸二甲酯纯剂型和胶囊剂型的新型高效液相色谱法","authors":"M. Mohamed","doi":"10.18689/mjai-1000116","DOIUrl":null,"url":null,"abstract":"Results: This method was validated according to ICH requirements for new methods, which include accuracy, precision, selectivity, robustness, ruggedness, LOD, LOQ, linearity and range. Linear relationships were obtained in the ranges of 5-160 μg/mL with correlation coefficients of 0.9997. The forced degradation studies as acidity, alkalinity, oxidation, heat, and thermal, humidity and photo degradation were performed according to ICH guidelines.","PeriodicalId":431351,"journal":{"name":"Madridge Journal of Analytical Sciences and Instrumentation","volume":"69 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2018-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":"{\"title\":\"Stability Indicating New-UPLC Method for Determination of Dimethyl Fumarate in their Pure and Capsule Dosage Form\",\"authors\":\"M. Mohamed\",\"doi\":\"10.18689/mjai-1000116\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Results: This method was validated according to ICH requirements for new methods, which include accuracy, precision, selectivity, robustness, ruggedness, LOD, LOQ, linearity and range. Linear relationships were obtained in the ranges of 5-160 μg/mL with correlation coefficients of 0.9997. The forced degradation studies as acidity, alkalinity, oxidation, heat, and thermal, humidity and photo degradation were performed according to ICH guidelines.\",\"PeriodicalId\":431351,\"journal\":{\"name\":\"Madridge Journal of Analytical Sciences and Instrumentation\",\"volume\":\"69 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2018-09-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Madridge Journal of Analytical Sciences and Instrumentation\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18689/mjai-1000116\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Madridge Journal of Analytical Sciences and Instrumentation","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18689/mjai-1000116","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Stability Indicating New-UPLC Method for Determination of Dimethyl Fumarate in their Pure and Capsule Dosage Form
Results: This method was validated according to ICH requirements for new methods, which include accuracy, precision, selectivity, robustness, ruggedness, LOD, LOQ, linearity and range. Linear relationships were obtained in the ranges of 5-160 μg/mL with correlation coefficients of 0.9997. The forced degradation studies as acidity, alkalinity, oxidation, heat, and thermal, humidity and photo degradation were performed according to ICH guidelines.
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