ANALYTICAL METHODS FOR ESTIMATION OF MYCOPHENOLIC ACID IN BULK AND IN PHARMACEUTICAL DOSAGE FORM: A REVIEW

A. U. Manjare, R. Kale
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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. Keywords: Mycophenolic acid, Immunosuppressant, HPLC, UV, Validation
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原料药和制剂中霉酚酸含量的分析方法综述
霉酚酸是一种抗代谢免疫抑制剂。它还能抑制肌苷一磷酸脱氢酶;嘌呤合成所必需的。高效液相色谱法(HPLC)和紫外分光光度法(UV)是药品评价中必不可少的分析工具。HPLC方法应该能够分离、检测和列举在储存或生产过程中可能形成的各种药物和药物相关降解物。它还应检测和列举在合成过程中可能引入的任何药物和药物相关杂质。验证是建立一种方法的性能特征和局限性,并确定可能改变这些特征的影响及其程度的过程。本文讨论了药物霉酚酸的现状和潜在用途,以及设计紫外和高效液相色谱方法进行开发和验证的计划和课题。关键词:霉酚酸;免疫抑制剂;高效液相色谱法
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