Stability-indicating assay method for determination of actarit,its process related impurities and degradation products:Insight into stability profile and degradation pathways

作     者：A.Abiramasundari Rahul P.Joshi Hitesh B.Jalani Jayesh A.Sharma Dhaivat H.Pandya Amit N.Pandya Vasudevan Sudarsanam Kamala K.Vasu 

作者机构：Department of Medicinal Chemistry B.V. Pat el PERD Centre Ahmedcibad Gujarat 380054 India 

出 版 物：《Journal of Pharmaceutical Analysis》 (药物分析学报（英文版）)

年 卷 期：2014年第4卷第6期

页      面：374-383页

学科分类：1007[医学-药学(可授医学、理学学位)] 081704[工学-应用化学] 07[理学] 08[工学] 0817[工学-化学工程与技术] 070302[理学-分析化学] 0703[理学-化学] 10[医学] 

主　　题：Actarit Forced degradation Stability-indicating assay method 

摘      要：The stability of the drug actarit was studied under different stress conditions like hydrolysis（acid,alkaline and neutral）,oxidation,photolysis and thermal degradation as recommended hy International Conference on Harmonization（ICH） *** was found to be unstable in acidic,basic and photolytic conditions and produced a common degradation product while oxidative stress condition produced three additional degradation *** was impassive to neutral hydrolysis,dry thermal and accelerated stability *** products were identified,isolated and characterized by different spectroscopic *** and the degradation products were synthesized by a new route using green *** chromatographic separation of the drug and its impurities was achieved in a phenomenex luna C18 column employing a step gradient elution by high performance liquid chromatography coupled to photodiode array and mass spectrometry detectors（HPLC-PDAMS）.A specilic and sensitive stability-indicating assay method for the simultaneous determination of the drug *** process related impurities and degradation products was developed and validated.