Abstract

METHODS FOR ANALYSIS OF GALANTAMINE HYDROBROMIDE

Dobrina D. Tsvetkova, Stefka A. Ivanova, Danka P. Obreshkova, Valentina B. Petkova*, Peter Atanasov, Pavlina D. Yordanova-Laleva and Aleksandar S. Pashev

ABSTRACT

The overproduction of reactive oxygen species and the weakening of the antioxidant defense mechanisms in human body are the main reason for the oxidative stress, which underlies the development of neurodegenerative Alzheimer’s disease. The important strategy for treatment of Alzheimer's disease is with compounds such as natural product Galantamine which increases acetylcholine, inhibites -secretase and inflammation and scavenges the free radicals. In European and USP Pharmacopoeias is recommended a gradient HPLC method for the determination of the maximum content of related substances in Galantamine hydrobromide substance. For analysis of Galantamine hydrobromide substance, HPLC methods with UV and mass-detection have been developed. For determination of Galantamine hydrobromide in tablets, the following methods have been described: UV-spectrophotometry at λ = 287 nm and λ = 289 nm; UV-spectrophotometry – first derivative at λ = 277.4 nm and λ = 284.8 nm; fluorimetry at λexcitation = 282 nm and λemmmsion = 607 nm; HPLC with UV and fluorescence detection. For quantification of Galantamine hydrobromide in biological fluids, the following methods have been presented: 1) fluorimetry; 2) capillary zone electrophoresis (serum, urine); 3) micellar electrokinetic chromatography; 4) HPLC methods with UV, fluorescence and mass detection. For the quantification of Galantamine hydrobromide in plasma after liquid-liquid extraction with hexane : ethylacetate, diethyl ether, toluene, trichloromethane or ethylacetate, an HPLC-methods with UV-detection at λ = 224 nm, fluorescence and mass detection with ionization at atmospheric pressure have been proposed. Sulpiride, Loratadine, isotopically labeled Galantamine or Glimepride have been applied as internal standards.

Keywords: Galantamine hydrobromide, methods, determination.