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Abstract
Memantine is one of the first novel class medications for treatment of Alzheimer's disease. In
this study a simple, rapid and precise gas chromatographic method has been developed for the
Memantine hydrochloride, using HP-5, 30m,0.32mm,0.25µm column and nitrogen as a carrier
gas at a flow rate of 3 ml/min.The oven temperature was programmed at 50°C for 1 min,with a rise
of 10°C /min up to 250°(Hold for 25 min).The injector and detector port temperatures were
maintained at 120°C and 280°C.Detection was carried out using Flame ionization detector. Results
of assay and recovery studies were statistically evaluated for its accuracy and precision.
Article Outline:
1. Introduction
2. Experimental
2.1 Instrumentation
4. Conclusion
1. INTRODUCTION
2.1 Instrumentation
For all Experiments ‘Agilent gas chromatograph (Model: 6890) with liquid injector 7683B
apparatus with flame ionization detector was used. The stationary phase was HP-5,30 m x 0.25
mm x 0.25µm (Make: J &W scientific, Part No:19091L-413)
2.2 Solvents, chemicals and materials
All experiments were performed using ‘A’ class volumetric glassware and an in-house
standard of Memantine hydrochlorie.HPLC grade Touene(Rankem,india) and highly pure
HPLC grade Milli Q water(Millipore,Bedford,MA,USA) were used in preparation of standard
and samples.
Specificity
The aim of specificity study is to assess the non interference of components. The
specificity of method was checked per diluent interference as well as all the other excipients
interference. Diluent and subsequenty placebo mixture(in duplicate) were injected to check
any interference. No peak due to placebo was detected at retention time of analyte peak. The
study proves that the test method is specific for quantification.
Precision
System suitability
System suitability shall be checked for the conformance of the suitability &
reproducibility of chromatographic system for analysis. System suitability was checked by
injecting six replicate injections of standard solution. % RSD for standard peak shall be not
more than 2.0
Method Precision
The purpose of this experiment is to prove the repeatability of the results obtained by
this quantification methodology. To confirm this six sample solutions were injected and
%RSD of the results was observed. The resulting RSD was 2.2% and well within the
acceptance limit and showed the method precise.
Intermediate