Photo- and thermal-stability studies on benzimidazole anthelmintics by HPLC and GC-MS.
Photo- and thermal-stability of the anthelmintics Albendazole, Mebendazole and Fenbendazole as in solid as in solution form has been investigated, by using a Xenon arc lamp as a radiation source, according to the ICH guideline for the drug stability tests. The degradation process was monitored by a HPLC method. All drugs showed high photosensitivity in solution but a reliable stability in solid form and when exposed to a temperature up to 50 degrees C. Two main degradation products from hydrolysis of the carbamic groups were identified by GC-MS. Validation studies demonstrated high accuracy (recovery 94 to 106%) and precision (RSD under 4.6%) of the HPLC method. The analytical procedure was successfully applied to the control of the drugs in the respective pharmaceutical formulations.
Ragno
Gaetano
G
Department of Pharmaceutical Sciences, Pharmacy Faculty, University of Calabria, Rende, CS, Italy. ragno@unical.it
Risoli
Antonella
A
Ioele
Giuseppina
G
De Luca
Michele
M
D000871:Anthelmintics / Q000737:chemistry*; D001562:Benzimidazoles / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004355:Drug Stability; D008401:Gas Chromatography-Mass Spectrometry / Q000379:methods*; D010777:Photochemistry; D013696:Temperature
D000871:Anthelmintics; D001562:Benzimidazoles; C031000:benzimidazole