Photo- and thermal-stability studies on benzimidazole anthelmintics by HPLC and GC-MS

Chem Pharm Bull (Tokyo). 2006 Jun;54(6):802-6. doi: 10.1248/cpb.54.802.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anthelmintics / chemistry*
  • Benzimidazoles / chemistry*
  • Chemistry, Pharmaceutical
  • Chromatography, High Pressure Liquid / methods
  • Drug Stability*
  • Gas Chromatography-Mass Spectrometry / methods*
  • Photochemistry
  • Temperature

Substances

  • Anthelmintics
  • Benzimidazoles
  • benzimidazole