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Spectrophotometric Determination of Four Macrolide Antibiotics in Pharmaceutical Formulations and Biological Fluids via Binary Complex Formation with Eosin and Spectrophotometry

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A simple, rapid, and sensitive validated spectrophotometric method was developed for the determination of certain macrolide antibiotics namely, erythromycin (I), azithromycin dihydrate (II), clarithromycin (III), and roxithromycin (IV) in bulk powders, pharmaceutical formulations, and spiked biological fluids. The proposed method is based on the formation of a binary complex between each of the studied drugs and eosin Y in aqueous buffered medium. Under the optimum conditions, the binary complexes showed absorption maxima at 542544 nm. The absorbance of the binary complexes obeyed Beer's law over the concentration range of 110 g/mL for II, 220 g/mL for I and IV, and 330 g/mL for III. The mean percentage recoveries were 100.04 0.83, 99.98 0.80, 100.17 0.91, and 99.55 0.91, with minimum detectable molarities of 2 107 for I and II, 4 107 for III, and 3 107 for IV. The different experimental parameters affecting the development and stability of the colors were studied and optimized. The proposed method was successfully applied to the analysis of the cited drugs in some pharmaceutical formulations. The results obtained were in good agreement with those obtained using the reference methods. The proposed method was further applied to spiked human urine and plasma. A proposal of the reaction pathway is suggested.
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Document Type: Research Article

Affiliations: 1: University of Mansoura, Faculty of Pharmacy, Department of Analytical Chemistry, Mansoura 35516, Egypt. 2: University of Helwan, Faculty of Pharmacy, Department of Analytical Chemistry, Cairo, Egypt.

Publication date: November 1, 2007

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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