Identification and Characterization of Unknown Degradation Impurities in Beclomethasone Dipropionate Cream Formulation using HPLC, ESI-MS and NMR

Publication date: Available online 10 February 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Sambandan Elumalai, Kathavarayan Thenmozhi, Sellappan Senthilkumar, Jentaie Shiea, Ponnusamy Vinoth KumarAbstractThe present study focuses on identifying the degradation profile and pathways of unknown impurities from beclomethasone dipropionate (BDP) topical cream formulation reported under accelerated stability conditions. Six degradation impurities were observed during the accelerated stability testing of BDP topical cream formulation, and these thermally labile degradation impurities were primarily identified using a simple, effective and mass compatible isocratic reversed-phase high-performance liquid chromatography with ultraviolet detection method. The degradation impurities found in this sample were of very low concentration levels, thus the concentration of these impurities in the sample was enriched by mimicking the thermal degradation conditions to structurally elucidate the unknown impurities. These BDP thermal degradation impurities were isolated using preparative liquid chromatography and followed by pre-concentration using rota-vapour. Further, the collected thermal degradation impurities were characterized using ESI-MS, and the major impurity was identified using 1H and C13 NMR spectroscopy, and DEPT technique. Plausible degradation pathway and mechanism of each impurity from BDP has been proposed based on the obtained mass and NMR spectral da...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research

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Date: Thursday, 12 12, 2019; Speaker: Julie Blendy , Ph.D. Professor of Pharmacology, Perelman School of Medicine, University of Pennsylvania; Building: Building 40; 1201/1203
Source: NIH Calendar of Events - Category: American Health Source Type: events
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Date: Monday, 01 27, 2020; Speaker: Lisa Ingraham, Ph.D., University of California, San Francisco; Porter Neuroscience Bldg, 35a; G620-640; Videocast Event
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Date: Friday, 11 22, 2019; Speaker: various; Building 38; Conference room B, second floor
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