Фармацевтика Аналитика Акта

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A Validated Time of Flight Mass Spectrometry for Quantitative Determination of Amantadine Hydrochloride and Memantine Hydrochloride

Nahla Nour Salama, Shudong Wang and Elham Taha

Introduction: Time of flight mass spectrometry was developed and validated for quantitative determination of amantadine and memantine in drug substances and products. Materials and methods: The method was based on time of flight electron spray ionization mass spectrometry technique without preliminary chromatographic separation and made use of memantine as internal standard of amantadine, which is used as internal standard of memantine. Results and conclusion: A linear relationship between drug concentrations and peak intensity ratios of ions of the analyzed substances is established in range of 23.80-2380.00 ng mL-1 for amantadine and memantine (r=> 0.998, n=6). The method is robust and reproducible with intra-and inter-assay precision (RSD % < 2.0%). The quantification limit was 23.8 ng mL-1 for both drugs. The described method has advantages over the reported methods as the assay was completed in less than 2 min with high accuracy and selectivity.