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  • Title: Compatibility of atenolol with excipients: LC-MS/TOF characterization of degradation/interaction products, and mechanisms of their formation.
    Author: Kumar V, Shah RP, Malik S, Singh S.
    Journal: J Pharm Biomed Anal; 2009 May 01; 49(4):880-8. PubMed ID: 19217740.
    Abstract:
    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.
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