Development of forced degradation and stability indicating studies of drugs—A review
نویسندگان
چکیده
منابع مشابه
Development of forced degradation and stability indicating studies of drugs—A review
Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation s...
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Stress Degradation Studies of Telmisartan and Hydrochlorothiazide and Development of Validated Stability Indicating Method
Telmisartan and Hydrochlorothiazide were subjected to different ICH prescribed stress conditions like acidic, alkaline, oxidation, reduction, thermal and photostability condition and found that degraded peaks did not interfere with the peaks of drug under the study. A stability indicating HPLC method was developed for analysis of the drug in the presence of degradation products involved a Enabl...
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This study describes the development and validation of stability indicating RP-HPLC method for Mirtazapine, an antidepressant drug. In order to investigate the stability of drug, a stress testing of drug sample by exposing it to variety of forced degradation conditions has been recommended. Mirtazapine was subjected to stress degradation 1 under different conditions recommended by International...
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A simple, rapid and stability-indicating reversed-phase liquid chromatographic method was developed for the assay of varenicline tartrate (VRT) in the presence of its degradation products generated from forced decomposition studies. The HPLC separation was achieved on a C18 Inertsil column (250 mm × 4.6 mm i.d. particle size is 5 μm) employing a mobile phase consisting of ammonium acetate buffe...
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ژورنال
عنوان ژورنال: Journal of Pharmaceutical Analysis
سال: 2014
ISSN: 2095-1779
DOI: 10.1016/j.jpha.2013.09.003