کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1221784 967843 2010 13 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Characterization of degradation products of amorphous and polymorphic forms of clopidogrel bisulphate under solid state stress conditions
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Characterization of degradation products of amorphous and polymorphic forms of clopidogrel bisulphate under solid state stress conditions
چکیده انگلیسی

The present study deals with the stress degradation studies on amorphous and polymorphic forms of clopidogrel bisulphate. The objective was to characterize the degradation products and postulate mechanism of decomposition of the drug under solid state stress conditions. For that, amorphous form, polymorph I and polymorph II of the drug were exposed to 40 °C/75% relative humidity (RH), with and without stressors for 3 months. The samples were analyzed by HPLC, and the relative extent of degradation as well as nature of decomposition was compared among three solid forms. In total, eight degradation products were observed under various stress conditions. The structures of all of them were elucidated using LC–MS/TOF and LC–MSn studies. While one matched the known hydrolytic decomposition product of the drug in solution, seven others were new. The postulated degradation pathway and mechanism of decomposition are discussed.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 52, Issue 3, 8 July 2010, Pages 332–344
نویسندگان
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