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Evaluation of the Chemical Integrity of Beta-Lactam Antibiotics by Iodine-Based Assay

Journal of Biosciences and Medicines 2015年第11期3卷 91-99页

作者： Abraham Salois Iris Perez Ervin Palma ethan goolish Yuri Griko Chief Dull Knife College Lame Deer USA Evergreen Valley College San Jose USA California State University Eastbay Hayward USA Mountain View High School Mountain View USA National Aeronautics and Space Administration Ames Research Center Moffett Field USA

One of the major problems associated with the therapeutic application of β-lactam antibiotics is their significant instability [1]-[3]. Analogs from that group are easily degraded in aqueous solutions and in solid state, which happens predominantly as a result of β-lactam ring chemical degradation. Because of this, the chemical integrity of β-lactam antibiotics must be closely monitored to meet FDA requirements. The original iodometric method based on visual detection of the end products of beta-lactamase hydrolysis that has been used to test beta-lactamase activity [4] was modified to quantitatively assess the amount of degraded product in amoxicillin. A UV-visible spectrophotometric method has been used, focusing on the ability of the products from the degradation of β-lactam analogs to absorb iodine from bulk solution, resulting in a significant reduction in the absorption spectra. Amoxicillin trihydrate tablets with different expiration dates and amoxicillin samples pre-loaded with known amounts of degraded amoxicillin have been used to generate a calibration curve and quantify the presence of degraded materials. Results show that the changes in the absorption spectra of iodine reagent directly correlate with the fraction of degraded β-lactam antibiotics, such as amoxicillin, in commercial products. The proposed assay might be as close as one step from simpler and cheaper methods of quantitative analysis of degraded β-lactam analogs, with estimated sensitivity in the range of 1% - 2%, which is better than the current FDA requirements.

关键词： Amoxicillin Iodine Chemical Integrity

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