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1篇 您的检索式:作者名="Amit N.Pandya"
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1Stability-indicating assay method for determination of actarit,its process related impurities and degradation products:Insight into stability profile and degradation pathways显示文摘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) guidelines.Drug 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 products.Drug was impassive to neutral hydrolysis,dry thermal and accelerated stability conditions.Degradation products were identified,isolated and characterized by different spectroscopic analyses.Drug and the degradation products were synthesized by a new route using green chemistry.The 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 actarit.its process related impurities and degradation products was developed and validated.A.Abiramasundari Rahul P.Joshi Hitesh B.Jalani Jayesh A.Sharma Dhaivat H.Pandya Amit N.Pandya Vasudevan Sudarsanam Kamala K.Vasu 2014Journal of Pharmaceutical Analysis2014,4,6:1
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