{"title":"原料药和制剂中霉酚酸含量的分析方法综述","authors":"A. U. Manjare, R. Kale","doi":"10.32553/IJPBA.V7I3.127","DOIUrl":null,"url":null,"abstract":"Mycophenolic acid is an anti-metabolite immunosuppressant. It also inhibits the enzyme inosine monophosphate dehydrogenase; essential for purine synthesis. High performance liquid chromatography (HPLC) and the UV are an essential analytical tools in assessing drug product. HPLC methods should be able to isolate, detect, and enumerate the various drugs and drug associated degradants that can form on storage, or manufacturing. It should also detect and enumerate any drugs and drug-related impurities that may be introduced during synthesis. Validation is the process of establishing the performance characteristics and limits of a method and identification of the effects which may change these features and to what extent. This article discusses the current and potential uses of the drug mycophenolic acid as well as the plans and the subjects related to designing UV and HPLC method for development and validation. \nKeywords: Mycophenolic acid, Immunosuppressant, HPLC, UV, Validation","PeriodicalId":14229,"journal":{"name":"International Journal of Pharmaceutical and Biological Science Archive","volume":"58 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2019-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"ANALYTICAL METHODS FOR ESTIMATION OF MYCOPHENOLIC ACID IN BULK AND IN PHARMACEUTICAL DOSAGE FORM: A REVIEW\",\"authors\":\"A. U. Manjare, R. Kale\",\"doi\":\"10.32553/IJPBA.V7I3.127\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Mycophenolic acid is an anti-metabolite immunosuppressant. It also inhibits the enzyme inosine monophosphate dehydrogenase; essential for purine synthesis. High performance liquid chromatography (HPLC) and the UV are an essential analytical tools in assessing drug product. HPLC methods should be able to isolate, detect, and enumerate the various drugs and drug associated degradants that can form on storage, or manufacturing. It should also detect and enumerate any drugs and drug-related impurities that may be introduced during synthesis. Validation is the process of establishing the performance characteristics and limits of a method and identification of the effects which may change these features and to what extent. This article discusses the current and potential uses of the drug mycophenolic acid as well as the plans and the subjects related to designing UV and HPLC method for development and validation. \\nKeywords: Mycophenolic acid, Immunosuppressant, HPLC, UV, Validation\",\"PeriodicalId\":14229,\"journal\":{\"name\":\"International Journal of Pharmaceutical and Biological Science Archive\",\"volume\":\"58 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-05-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Pharmaceutical and Biological Science Archive\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.32553/IJPBA.V7I3.127\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmaceutical and Biological Science Archive","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.32553/IJPBA.V7I3.127","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
ANALYTICAL METHODS FOR ESTIMATION OF MYCOPHENOLIC ACID IN BULK AND IN PHARMACEUTICAL DOSAGE FORM: A REVIEW
Mycophenolic acid is an anti-metabolite immunosuppressant. It also inhibits the enzyme inosine monophosphate dehydrogenase; essential for purine synthesis. High performance liquid chromatography (HPLC) and the UV are an essential analytical tools in assessing drug product. HPLC methods should be able to isolate, detect, and enumerate the various drugs and drug associated degradants that can form on storage, or manufacturing. It should also detect and enumerate any drugs and drug-related impurities that may be introduced during synthesis. Validation is the process of establishing the performance characteristics and limits of a method and identification of the effects which may change these features and to what extent. This article discusses the current and potential uses of the drug mycophenolic acid as well as the plans and the subjects related to designing UV and HPLC method for development and validation.
Keywords: Mycophenolic acid, Immunosuppressant, HPLC, UV, Validation
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
