Volume : 5, Issue : 8, AUG 2019

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF MEMANTINE HYDROCHLORIDE IN THE PRESENCE OF ITS RELATED COMPOUNDS BY GAS CHROMATOGRAPHY

B.SRIDEVI*, DR. M. AJITHA, K.S.L. HARIKA

Abstract

A simple ,reliable,economical,and accurate Gas chromatographic method was developed for the estimation of Memantine Hcl Impurities in ER Tablet dosage form .The chromatographic separation was achieved on a chromatography column (stationary phase) is AT-5,length30m,internal diameter 0.25mm and film thickness1.0µ. The gas flow rate is 4.0ml/min and the load is 2µl .Diluent –n-hexane. The Rt valve of Memantine Hcl, Impurity-E was found to be 19.9 min, 28.1 min respectively. The developed method was validated for linearity, accuracy, precision, specificity, system suitability, and solution stability. Results of all validation parameters were within the limits as per ICH Guidelines.

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References

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