期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 49, 期 4, 页码 880-888出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2009.01.014
关键词
Atenolol; Excipients; Degradation/interaction products; LC-MS/TOF; Identification
资金
- Dr. Reddy's Laboratories Ltd., Hyderabad, India
A Study was carried out to investigate compatibility of atenolol, a beta(1) blocker, with a variety of pharmaceutical excipients. The binary mixtures (1:1) of atenolol with the excipients were stored for 1 month at 40 degrees C/75% RH. The samples were directly observed for the physical changes, and also analyzed by a validated HPLC method to determine the chemical changes. The study revealed that atenolol was incompatible with ascorbic acid, citric acid and butylated hydroxyanisole. The degradation/interaction products formed in these mixtures were characterized by high resolution mass spectrometric and fragmentation analyses, using a LC-MS/TOF system. The identity of characterized structures was justified through mechanistic explanations. (c) 2009 Elsevier B.V. All rights reserved.
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