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Effect of Radiation Sterilization on Alprenolol in the Solid State Studied by High-Performance Thin-Layer Chromatography

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The possibility of radiation sterilization of alprenolol (AL) has been studied. Irradiation of AL in solid form with a 25 kGy beam of electrons caused only an insignificant change in color that became more intense with increasing irradiation dose. Moreover, with increasing dose a decrease in pH, the content of water, and the degree of crystallinity were observed. AL in solid form was radiated with a high-energy electron beam (9.96 MeV) at doses from 25400 kGy and analyzed by HPTLC using the mobile phase methanolammonia 25 (99 + 1, v/v). Densitometric analysis was carried out directly from chromatograms at 270 nm. The applied method was validated and characterized by good precision (RSD = 3.95); good accuracy (80 level 100.15, 100 level 99.99, and 120 level 104.44); and low LOD (LOD = 0.52 g/zone and LOQ = 1.55 g/zone). Chromatograms recorded for samples irradiated at the doses of 25 kGy were unchanged, but at higher doses (100400 kGy) additional peaks corresponding to the radiodegradation products appeared (Rf = 0.24 and Rf = 0.40). The decrease in the concentration of AL was proportional to the applied radiation dose, and for 400 kGy the concentration of AL was 90.23. The calculated radiolytic yield of the radiodegradation process was G(AL) = 7.12 107 mol/J.
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Document Type: Research Article

Affiliations: 1: Poznan University of Medical Sciences, Department of Pharmaceutical Chemistry, Grunwaldzka 6, 60-780 Pozna, Poland. 2: Jagiellonian University, Collegium Medicum, Department of Inorganic and Analytical Chemistry, Medyczna 9, 30-688 Krakw, Poland.

Publication date: May 1, 2010

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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 The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better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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