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The Development and Validation of Novel, Simple High-Performance Liquid Chromatographic Method with Refractive Index Detector for Quantification of Memantine Hydrochloride in Dissolution Samples.

作者信息

Sawant Tukaram B, Wakchaure Vikas S, Rakibe Udyakumar K, Musmade Prashant B, Chaudhari Bhata R, Mane Dhananjay V

机构信息

Wockhardt Research Centre (Global Technical Services), Aurangabad 431210, Maharashtra, India.

Dr. Babasaheb Ambedkar Marathwada University, Aurangabad 431004, Maharashtra, India.

出版信息

J Chromatogr Sci. 2017 Jul 1;55(6):603-609. doi: 10.1093/chromsci/bmx013.

DOI:10.1093/chromsci/bmx013
PMID:28334787
Abstract

The present study was aimed to develop an analytical method for quantification of memantine (MEM) hydrochloride in dissolution samples using high-performance liquid chromatography with refractive index (RI) detector. The chromatographic separation was achieved on C18 (250 × 4.5 mm, 5 μm) column using isocratic mobile phase comprises of buffer (pH 5.2):methanol (40:60 v/v) pumped at a flow rate of 1.0 mL/min. The column effluents were monitored using RI detector. The retention time of MEM was found to be ~6.5 ± 0.3 min. The developed chromatographic method was validated and found to be linear over the concentration range of 5.0-45.0 μg/mL for MEM. Mean recovery of MEM was found to be 99.2 ± 0.5% (w/w). The method was found to be simple, fast, precise and accurate, which can be utilized for the quantification of MEM in dissolution samples.

摘要

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