Simple Hplc Method Development for the Estimation of Galantamine Hydrobromide in Extended-Release Formulation

Author:

Gayke Amol U.,Shukla Karunakar,Jain Sourabh

Abstract

For the determination of Galantamine Hydrobromide in bulk and produced extended formulation, a new sensitive and quick HPLC technique was developed and validated according to ICH guidelines. The HPLC analysis was carried out using a waters system with a Thermo Scientific C18 (steel column (5 µm, 250mm × 4.6 mm)) column and a mobile phase of 0.1M phosphate buffer: Acetonitrile (40:60V/V) pH adjusted to 4.5 with orthophosphoric acid, at a flow rate of 1.0 mL/min. The detection was done at a wavelength of 203 nm, and galantamine hydrobromide had a retention time of 8.0 minutes. Over the concentration range of 1-10 g/ml, the calibration plot revealed a linear relationship. The accuracy of the proposed method was determined by recovery studies and was found to be near to 100 and % RSD value was found less than 2. The repeatability testing for both standard and sample solutions showed that the method is precise within the acceptable limits. RSD % of the determination of precision was <2%. The proposed method showed excellent linearity, accuracy, precision, specificity, robustness and system suitability results within the acceptance criteria. In addition, Saturation solubility of Galantamine Hydrobromide was determined in different pH mediums and it was found that Galantamine Hydrobromide has pH-dependent solubility, freely soluble in alkaline pH, and insoluble in acidic pH.

Publisher

Sciencedomain International

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3