HPLC-MS测定盐酸美金刚溶出度方法的建立与验证

IF 0.7 Q4 CHEMISTRY, ANALYTICAL Methods and Objects of Chemical Analysis Pub Date : 2021-01-01 DOI:10.17721/moca.2021.71-80
A. Yegorova, Yu. V. Skrypynets, I. Leonenko, G. Maltsev, S. Kashutskуy, O. Voitiuk
{"title":"HPLC-MS测定盐酸美金刚溶出度方法的建立与验证","authors":"A. Yegorova, Yu. V. Skrypynets, I. Leonenko, G. Maltsev, S. Kashutskуy, O. Voitiuk","doi":"10.17721/moca.2021.71-80","DOIUrl":null,"url":null,"abstract":"A method for quantitative determination of memantine hydrochloride by HPLC with mass spectrometric detection (HPLC-MS), suitable for the study of dissolution profiles of tablets \"Mematon IС\" was developed. Chromatographic determination was performed using a mobile phase of methanol - 0.1% (v/v) aqueous solution of formic acid (55:45) on a column of Zorbax Eclipse Plus C18 size 10 cm Ч 4.6 mm (3.5 μm) at a flow rate of 1 ml/min. The linearity interval in the appropriate dissolution media is 35 - 150 % of the normalized content of memantine hydrochloride in the tablet. The method is validated on the parameters of specificity, accuracy, correctness, linearity in the studied range of concentrations, robustness. The stability of the tested solutions and reference solutions in the case of their storage at room temperature for 24 hours was confirmed. It is established that in the case of the study of solutions prepared in a dissolution medium of 0.1 M hydrochloric acid solution pH 1.2, there is a need to preneutralize hydrochloric acid before analysis, because it, as stronger than formic acid, almost completely ionizes all dissolved molecules, which leads to a significant deviation of the linear dependence of the analytical signal on the concentration of the analyte. Neutralization is performed with 0.1 M sodium hydroxide solution, which is added to the sample of the test solution. The release of more than 85 % of memantine hydrochloride in 15 min in all dissolution media indicates the similarity of the dissolution profiles and does not require the calculation of the similarity factor f2.","PeriodicalId":18626,"journal":{"name":"Methods and Objects of Chemical Analysis","volume":"1 1","pages":""},"PeriodicalIF":0.7000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development and Validation of HPLC-MS Method of Determination of Memantine Hydrochloride for Study of Dissolution Profiles\",\"authors\":\"A. Yegorova, Yu. V. Skrypynets, I. Leonenko, G. Maltsev, S. Kashutskуy, O. Voitiuk\",\"doi\":\"10.17721/moca.2021.71-80\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A method for quantitative determination of memantine hydrochloride by HPLC with mass spectrometric detection (HPLC-MS), suitable for the study of dissolution profiles of tablets \\\"Mematon IС\\\" was developed. Chromatographic determination was performed using a mobile phase of methanol - 0.1% (v/v) aqueous solution of formic acid (55:45) on a column of Zorbax Eclipse Plus C18 size 10 cm Ч 4.6 mm (3.5 μm) at a flow rate of 1 ml/min. The linearity interval in the appropriate dissolution media is 35 - 150 % of the normalized content of memantine hydrochloride in the tablet. The method is validated on the parameters of specificity, accuracy, correctness, linearity in the studied range of concentrations, robustness. The stability of the tested solutions and reference solutions in the case of their storage at room temperature for 24 hours was confirmed. It is established that in the case of the study of solutions prepared in a dissolution medium of 0.1 M hydrochloric acid solution pH 1.2, there is a need to preneutralize hydrochloric acid before analysis, because it, as stronger than formic acid, almost completely ionizes all dissolved molecules, which leads to a significant deviation of the linear dependence of the analytical signal on the concentration of the analyte. Neutralization is performed with 0.1 M sodium hydroxide solution, which is added to the sample of the test solution. The release of more than 85 % of memantine hydrochloride in 15 min in all dissolution media indicates the similarity of the dissolution profiles and does not require the calculation of the similarity factor f2.\",\"PeriodicalId\":18626,\"journal\":{\"name\":\"Methods and Objects of Chemical Analysis\",\"volume\":\"1 1\",\"pages\":\"\"},\"PeriodicalIF\":0.7000,\"publicationDate\":\"2021-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Methods and Objects of Chemical Analysis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17721/moca.2021.71-80\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Methods and Objects of Chemical Analysis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17721/moca.2021.71-80","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
引用次数: 0

摘要

建立了适用于盐酸美金刚IС片溶出度分析的高效液相色谱-质谱法(HPLC- ms)定量测定盐酸美金刚的方法。色谱测定采用流动相甲醇- 0.1% (v/v)甲酸水溶液(55:45),色谱柱为Zorbax Eclipse Plus C18,尺寸为10 cm Ч 4.6 mm (3.5 μm),流速为1 ml/min。适宜溶出介质的线性区间为片中盐酸美金刚标准含量的35 ~ 150%。该方法的特异性、准确性、正确性、在所研究浓度范围内的线性、稳健性等参数均得到了验证。在室温下储存24小时的情况下,测试溶液和参考溶液的稳定性得到了证实。研究发现,在0.1 M盐酸溶液pH为1.2的溶解介质中制备的溶液中,分析前需要对盐酸进行预中和,因为盐酸比甲酸更强,几乎完全电离了所有溶解的分子,导致分析信号对分析物浓度的线性依赖性明显偏离。中和用0.1 M氢氧化钠溶液,加入到测试溶液的样品中。在所有溶出介质中,15分钟内释放量大于85%的盐酸美金刚表明溶出曲线相似,不需要计算相似因子f2。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Development and Validation of HPLC-MS Method of Determination of Memantine Hydrochloride for Study of Dissolution Profiles
A method for quantitative determination of memantine hydrochloride by HPLC with mass spectrometric detection (HPLC-MS), suitable for the study of dissolution profiles of tablets "Mematon IС" was developed. Chromatographic determination was performed using a mobile phase of methanol - 0.1% (v/v) aqueous solution of formic acid (55:45) on a column of Zorbax Eclipse Plus C18 size 10 cm Ч 4.6 mm (3.5 μm) at a flow rate of 1 ml/min. The linearity interval in the appropriate dissolution media is 35 - 150 % of the normalized content of memantine hydrochloride in the tablet. The method is validated on the parameters of specificity, accuracy, correctness, linearity in the studied range of concentrations, robustness. The stability of the tested solutions and reference solutions in the case of their storage at room temperature for 24 hours was confirmed. It is established that in the case of the study of solutions prepared in a dissolution medium of 0.1 M hydrochloric acid solution pH 1.2, there is a need to preneutralize hydrochloric acid before analysis, because it, as stronger than formic acid, almost completely ionizes all dissolved molecules, which leads to a significant deviation of the linear dependence of the analytical signal on the concentration of the analyte. Neutralization is performed with 0.1 M sodium hydroxide solution, which is added to the sample of the test solution. The release of more than 85 % of memantine hydrochloride in 15 min in all dissolution media indicates the similarity of the dissolution profiles and does not require the calculation of the similarity factor f2.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
1.00
自引率
14.30%
发文量
12
期刊介绍: The journal "Methods and objects of chemical analysis" is peer-review journal and publishes original articles of theoretical and experimental analysis on topical issues and bio-analytical chemistry, chemical and pharmaceutical analysis, as well as chemical metrology. Submitted works shall cover the results of completed studies and shall make scientific contributions to the relevant area of expertise. The journal publishes review articles, research articles and articles related to latest developments of analytical instrumentations.
期刊最新文献
Systematic Review and Guidelines for Management of Scrotal Inguinal Hernias. Study of the Biochemical Potential of Wild Fruit of the Caucasus Medar (Mespilus caucasics L.) in the Post-Harvest Period Chromatographic Determination of the Chemical Composition of Apple Chips Extract Development, Optimization, and Validation of a Novel HPLC Method for Simultaneous Quantification of Artesunate and Amodiaquine in Tablet Formulations Analytical Validation of a Reversed-Phase Ion Pairing HPLC-DAD Method for the Simultaneous Determination of Anthropogenic Pollutants
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1