Journal of Analytical & Bioanalytical Techniques
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Analytical method development and validation is a process used to confirm the analytical procedure employed for a specific
test suitable for its intended use. It helps to improve reliability, consistency and accuracy of analytical data. We have found
that the excipient in the tablet dosage forms does not interfere in the quantification of active drug by proposed method. This study
involves development and validation of chromatographic method of estimation of memantine Hcl in tablet dosage form as per
ICH guidelines with a validated reverse phase high performance chromatographic technique. Chromatography was performed on
Kromasil RP Column C
(150 mmx4.6 mm i.d.5 μm particle size) with mobile phase containing Acetonitrile (ACN). The flow rate
was 2 ml/min and eluent was detected at 263 nm at ambient temperature. The selected and proposed chromatographic conditions
were found effectively with retention time (RT- 1.766 min.) Linearity of memantine was found in the range of 80-120 mg/ml. This
method is fast, accurate, precise, reproducible and rugged and used for estimation of memantine in any type of pharmaceutical
dosage formulation. In this study, the RP-HPLC method of estimation of memantine has been performed according to the
current ICH guidelines. The results obtained in this study are statistically significant and found within the acceptance limit.
This simplified developed method was validated which reduces time, cost ultimately with better chromatographic separation as
considered with the other available known methods. Therefore the method is suitable for its intended use.
Memantine Hcl, RP-HPLC (Reverse Phase HPLC), Validation.
Vinod Jagannathrao Mokale has completed Master?s in Pharmacy at the age of 22 years from AISSMS College of Pharmacy, University of Pune,
Pune and submitted Ph.D. synopsis to North Maharashtra University, Jalgaon, India. He is the head of Department of Pharmaceutical Technology,
UICT, NMU, Jalgaon. He has published more than 13 papers in reputed journals and serving as guide for than 25 M. Tech. (Pharma. Tech.) Students
and given invited talk/lecture in international conferences.
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