Development and Validation of Analytical Method for Estimation of Memantine Hydrochloride

Research Article

Austin J Anal Pharm Chem. 2015; 2(4): 1047.

Development and Validation of Analytical Method for Estimation of Memantine Hydrochloride

Patel KH¹*, Patel SK¹, Karkhanis VV² and Captain AD³

¹Department of Quality Assurance, AR College of Pharmacy and GH Patel Institute of Pharmacy, India

²Department of Pharmaceutical Chemistry, AR College of Pharmacy and GH Patel Institute of Pharmacy, India

³Department of Pharmaceutical Analysis, AR College of Pharmacy and GH Patel Institute of Pharmacy, India

*Corresponding author: Kedar H Patel, Department of Quality Assurance, A.R. College of Pharmacy and G.H. Patel Institute of Pharmacy, India.

Received: May 05, 2015; Accepted: July 24, 2015; Published: July 28, 2015

Abstract

An accurate HPTLC analytical method for estimation of Memantine Hydrochloride was established and validated. Memantine Hydrochloride is an NMDA receptor antagonist and widely use for Alzheimer’s disease. The HPTLC method was developed using aluminum plates pre-coated with silica gel G60F254 as a stationary phase and n-Hexane: Ethyl acetate: Diethylamine (5:5:0.7 % v/v/v) as mobile phase. The separated spots were visualized as orange spots after dipping with Dragendorff’s reagent solution. The method was found to be Linear, Accurate, Precise, and Robust according to ICH Guideline. Linearity was found to be 5000-30000 ng/band for Memantine HCl. The LOD and LOQ were found to be 80.07ng/band and 242.637ng/band for Memantine HCl. So, developed method is applicable for the estimation of Memantine Hydrochloride.

Keywords: HPTLC; Memantine HCl; Alzheimer; Validation

Abbreviations

API: Active Pharmaceutical Ingredient; AR: Analytical Reagent Grade; B.P.: British Pharmacopoeia; CDSCO: Central Drug Standard Control Organization; HPLC: High Performance Liquid Chromatography; HPTLC: High Performance Thin Layer Chromatography; MEM: Memantine; ICH: International Conference on Harmonization; LOD: Limit Of Detection; LOQ: Limit Of Quantification; MS: Mass Spectroscopy; Rf: Retention Factor; RSD: Relative Standard Deviation; SD: Standard Deviation; UV: Ultra Violate; U.S.P.: United States Pharmacopoeia; USFDA: United States Food and Drug Administration.

Introduction

Memantine Hydrochloride is chemically 3,5-dimethyladamantan- 1-amine hydrochloride and it is an NMDA receptor antagonist and widely used for Alzheimer’s disease. It has empirical formula C12H21N•HCl with molecular weight 215.76 (g/mol) (Figure 1) [1]. Memantine HCl was first approved by FDA for treatment of Alzheimer’s disease on October 2003. Memantine HCl was approved by CDSCO on 6th September, 2010. Memantine HCl exerts its action through uncompetitive NMDA (N Methyl D aspartet) receptor antagonism, binding preferentially to the NMDA receptor-operated action channels. Prolonged increased levels of glutamate in the brain of demented patients are sufficient to counter the voltage-dependent block of NMDA receptors by Mg2+ ions and allow continuous influx of Ca2+ ions into cells, ultimately resulting in neuronal degeneration. Memantine binds more effectively than Mg2+ ions at the NMDA receptor, and thereby effectively blocks this prolonged influx of Ca2+ ions through the NMDA channel whilst preserving the transient physiological activation of the channels by higher concentrations of synoptically released glutamate. Thus memantine HCl protects against chronically elevated concentrations of glutamate. This research article reports a precise, accurate and sensitive HPTLC method, useful for routine quality control of Memantine HCl. The method was validated by parameters such as linearity, accuracy, precision and robustness. Memantine is official in USP-37 NF-32 [2]. Literature review reveals that the methods like HPLC, UV-Spectroscopic, LCMS/ MS, RP-HPLC, and UPLC have been reported for estimation of Memantine HCl in bulk and tablet dosage form [3-15]. But, No HPTLC method has been reported for the same. HPTLC method is widely used for routine drug analysis. Less amount of mobile phase is required which is one of the advantages of this method. Solvents need no prior treatment like filtration and degassing. High sample through put of similar or different nature of samples. Low cost pre coated HPTLC plates are available. Hence, this method is more economic and lower analysis time as compared to reported HPLC methods. This work deals with the validation of the developed method for the assay of Memantine HCl from tablet dosage form. Hence, the method is useful for routine quality control analysis. So, aim of dissertation work is to develop and validate precise and accurate HPTLC method.