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JOURNAL ARTICLE
VALIDATION STUDIES
Development and validation of a capillary zone electrophoretic method for rapid and sensitive determination of galanthamine: Application in plant and pharmaceuticals.
Journal of Pharmaceutical and Biomedical Analysis 2016 November 31
Galanthamine is a second-generation cholinesterase inhibitor that has begun to be used in the treatment of Alzheimer's disease. In the presented research, a simple, accurate, precise and cost-effective capillary zone electrophoretic (CZE) method was used for the qualitative and quantitative estimation of Galanthamine from bulbs, leaves and fringes of Leucojum aestivum L. (summer snowflake) grown in Turkish habitats (Black Sea Region) and pharmaceutical dosage forms by capillary zone electrophoresis with direct UV detection form. Ultrasonic assisted extraction (UAE) and response surface methodology (RSM) were used to estimate optimum experimental conditions on the content extraction of Leucojum aestivum L. Metoprolol was used as a suitable internal standard. A linear relationship between the ratio and concentrations of Galanthamine in the range of 0.25μgmL(-1)-15.00μgmL(-1)was determined with a regression coefficient of 0.9996, for which the limit of detection (LOD) and limit of quantitation (LOQ) were 0.027 and 0.081μgmL(-1), respectively. The high percentage recovery results showed that the matrix effect did not influence the developed method for analysis of pharmaceutical preparations. Validation parameters were carried out according to the guidelines of the International Conference for Harmonization (ICH). This method also allows for a number of cost- and time-saving benefits and can be readily employed for the analysis of plants and pharmaceutical formulations. The method can be used in industries for the determination of Galanthamine to analyze the quality of extraction and formulation without interference.
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