Development and validation of a gas chromatographic method for the assay of memantine hydrochloride in pure and tablet dosage forms

A gas chromatographic method has been developed and validated for the determination of memantine hydrochloride (MMT) in pure and pharmaceutical preparations. The detection was carried out using flame ionization detector. Separation was achieved on a DB-624 fused silica packed capillary column (30 m x 0.320 mm x 1.8 μm). Nitrogen was used as a carrier gas at a flow rate of 40 mL/min. The column temperature was maintained at 300°C while the temperature of injection port and detector were maintained at 270° and 300°C, respectively. Gabapentin (GPN) was used as an internal standard. The procedure gave a linear response over the concentration range of 0.5-3.5 mg/mL with sufficient reproducibility. The method has been applied successfully for the determination of MMT in pure and pharmaceutical formulations. The excipients present in the formulations did not interfere with the assay procedure. The recovery values were found to be in the range of 99.85-100.1% with RSD values less than 1%. The results obtained from this method were compared with the reference method (HPTLC) reported in literature and no significant difference was found statistically.