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

Autor: Barbara Marciniec, Anna Kwiecień, Magdalena Ogrodowczyk
Rok vydání: 2010
Předmět:
Zdroj: Scopus-Elsevier
ISSN: 1944-7922
1060-3271
DOI: 10.1093/jaoac/93.3.792
Popis: 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.
Databáze: OpenAIRE