Validation of an Analytical Method by Gas Chromatography for the Quantification of Memantine Hydrochloride

Abstract

Introduction: Alzheimer's disease is the leading cause of dementia in the world and affects the human brain irreversibly; the drug memantine hydrochloride is used for its treatment in the moderate and severe stages.

Objective: To validate an analytical method for the quantification of memantine hydrochloride in order to obtain safe and reliable results in humid tropical climate conditions by applying modifications.

Methods: A gas chromatographic method with flame ionization detector, 50 m x 0.32 mm column, 0.52 µm G27 packing, helium as carrier gas with flow rate of 4.0 mL/min, injector temperature at 220 °C, detector temperature at 300 °C, injection volume of 1 µL was used. Memantine hydrochloride was dissolved in basic medium for subsequent extraction with hexane and quantified with adamantane as internal standard. The parameters of specificity, linearity, accuracy, precision and robustness were evaluated.

Results: The method was linear, with a correlation coefficient of 0.999942, a coefficient of determination of 0.999885 and a coefficient of variation of the response factors of 0.7%, the variances did not differ significantly in the range of concentrations evaluated in linearity and accuracy, in the latter an average recovered amount of memantine hydrochloride of 101.4% was obtained, the coefficient of variation of the instrumental precision was 0.7% and the intermediate precision met according to the established criteria with a significance of 0.05. In specificity, no additional peak interferences were observed in the retention time of the main peak of the active principle and none of the variations made to the analytical method proved to be critical.

Conclusions: The validated analytical method by gas chromatography for the quantification of memantine hydrochloride, with the modifications made with respect to the method is specific, linear, accurate, precise and robust in the range of concentrations used for its application in quality control in humid tropical climate conditions.