Validation and application of a simple reverse phase HPLC method for in vitro dissolution studies of memantine hydrochloride tablet

초록

A simple, accurate and cost-effective ultraviolethigh performance liquid chromatography (UV-HPLC) assay method was developed and validated for the determination of derivatized memantine, a representative oral noncompetitive N-methyl-D-aspartate receptor antagonist to treat Alzheimer’s disease, in dissolution medium. Optimized derivatization process of memantine was performed with 9-fluorenylmethylchloroformate (FMOC), and injected with the UV-HPLC systemfor quantitation. Derivatizedmemantinewere separated on a reverse phase C18 column (Shiseido, 250 × 4.6 mm, 5 lm) with a mixture of 50 mM phosphate buffer (pH 4, adjusted with orthophosphoric acid) and Acetonitrile (20:80, v/v), at a flow rate of 2.0 mL/min.UVdetectionwas monitored at 265 nm. The detector response was specific and linear over the concentration range of 1.0–20.0 lg/mL. Validation parameters of derivatized memantine with the sensitivity, selectivity, linearity, accuracy, precision and stability in dissolution medium (pH 1.2) were acceptable based on International Conference on Harmonization Q2 (R1). The assay method validated in this work was successfully applied for a dissolution study of a commercial tablet containingmemantine hydrochloride (i.e., EbixaⓇ, 10 mg). Thus, the developed method would be appropriate for routine in vitro dissolution studies of memantine hydrochloride tablet.

키워드