title: Quantitation of memantine hydrochloride bulk drug and its tablet formulation using proton nuclear magnetic resonance spectrometry.
abstract: The use of quantitative nuclear magnetic resonance spectrometry for the determination of non-UV active memantine hydrochloride with relative simplicity and precision has been demonstrated in this study. The method was developed on a 500 MHz NMR instrument and was applied to determination of the drug in a tablet formulation. The analysis was performed by taking caffeine as an internal standard and D2 O as the NMR solvent. The signal of methyl protons of memantine hydrochloride appeared at 0.75 ppm (singlet) relative to the signal of caffeine (internal standard) at 3.13 ppm (singlet). The method was found to be linear (r(2)  = 0.9989) in the drug concentration range of 0.025 to 0.80 mg/ml. The maximum relative standard deviation for accuracy and precision was <2. The limits of detection and quantification were 0.04 and 0.11 mg/ml, respectively. The robustness of the method was revealed by changing nine different parameters. The deviation for each parameter was also within the acceptable limits. The study highlighted possibility of direct determination of memantine hydrochloride in pure form and in its marketed tablet formulation by the use of quantitative NMR, without the need of derivatization, as is the requirement in HPLC studies. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar-160 062, Punjab, India.
authors.forename: Archana
authors.initials: A
authors.lastname: Sahu
authors.affiliation: Biocon-BMS R&D Centre (BBRC), Biocon Park, Bangalore, India.
authors.forename: Mallikarjun
authors.initials: M
authors.lastname: Narayanam
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar-160 062, Punjab, India.
authors.forename: Moolchand
authors.initials: M
authors.lastname: Kurmi
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar-160 062, Punjab, India.
authors.forename: Mayurbhai Kathadbhai
authors.initials: MK
authors.lastname: Ladumor
authors.affiliation: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar-160 062, Punjab, India.
authors.forename: Saranjit
authors.initials: S
authors.lastname: Singh
mesh_terms: D000465:Algorithms; D000978:Antiparkinson Agents / Q000032:analysis*; D002110:Caffeine / Q000032:analysis; D004339:Drug Compounding; D057230:Limit of Detection; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D008559:Memantine / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D013607:Tablets
chemical_list: D000978:Antiparkinson Agents; D013607:Tablets; D002110:Caffeine; D008559:Memantine
keywords: assay; bulk drug; memantine; method validation; quantitative proton NMR; tablet