Abstract
Author(s): M. Gnana Raja, G. Geetha, A. Sankaranarayanan
The present paper deals with the development and validation of multi media dissolution of Memantine HCl tablets by precolumn derivatization by Phenoxy acetyl chloride (PAC) and Amantadine HCl, used as derivatizing agent and internal standard respectively. Memantine base was extracted from aqueous medium by basic toluene and added suitable volume of 0.15% v/v PAC solution in toluene. The solution was kept for five minutes for completion of the reaction and stopped the reaction by an organic solvent. The chromatographic was achieved by injecting 20 micro liter of derivatized mixture in HPLC column Inertsil ODS 3V [250*4.6] 5 micron. The mobile phase has 15% of 3% w/v ammonium acetate solution in methanol and the flow rate was maintained 1.5mL/minutes. Amantadine HCl was used as an internal standard, the Amantadine and Memantine peaks were eluted at the retention time of about 5.3 and 8.2 respectively. The volume, concentration and time have been optimized for derivatizing reagent and the key functional group has been assayed by Quantitative IR spectrum. After developed and validated method was used for multimedia dissolution profile was performed for 0.1N Hydrochloric acid, 0.1N Hydrochloric acid with 2% sodium chloride, pH 4.5 acetate buffer, pH 6.8 phosphate buffer and pH 7.2 phosphate buffer. Dissolution was performed 900mL of each media, Basket and 100rpm
