琥珀酸舒马普坦片剂剂型定量核磁共振波谱法的研制与验证

Mangarao Nakka
{"title":"琥珀酸舒马普坦片剂剂型定量核磁共振波谱法的研制与验证","authors":"Mangarao Nakka","doi":"10.20902/ijctr.2018.110502","DOIUrl":null,"url":null,"abstract":"A new, simple and accurate quantitative proton nuclear magnetic resonance(qNMR) spectroscopic  method was developed to determine the sumatriptan succinate in pharmaceutical tablet formulation. In this developed quantitative nuclear magnetic resonance spectroscopy method,Maleic acid was used as internal standard(IS) due to there was no overlapping of the peak  to analyte peaks and deuterium oxide(D2O) was used as diluent. For the quantification of the sumatriptan succinate 4.43 ppm and 6.20 ppm  peaks were used as quantitative monitoring purpose to correspong to analyte sumatriptane succinate and Maleic acid internal standard(IS) respectively. The final optimized  method was validated as per International Conference on Hormonisation (ICH) guidelines in terms  of Specificity, Limit of detection (LOD), Limit of Quantitation (LOQ), Pecision, Linearity, Accuracy ,Solution stability and Robustness. This method could be used to determination of sumatriptane succinate  in bulk and  pharmaceutical  tablet dosage forms.","PeriodicalId":13780,"journal":{"name":"International Journal of Chemical and Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"QUANTITATIVE NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION OF SUMATRIPTAN SUCCINATE IN PHARMACEUTICAL TABLET DOSAGE FORM\",\"authors\":\"Mangarao Nakka\",\"doi\":\"10.20902/ijctr.2018.110502\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A new, simple and accurate quantitative proton nuclear magnetic resonance(qNMR) spectroscopic  method was developed to determine the sumatriptan succinate in pharmaceutical tablet formulation. In this developed quantitative nuclear magnetic resonance spectroscopy method,Maleic acid was used as internal standard(IS) due to there was no overlapping of the peak  to analyte peaks and deuterium oxide(D2O) was used as diluent. For the quantification of the sumatriptan succinate 4.43 ppm and 6.20 ppm  peaks were used as quantitative monitoring purpose to correspong to analyte sumatriptane succinate and Maleic acid internal standard(IS) respectively. The final optimized  method was validated as per International Conference on Hormonisation (ICH) guidelines in terms  of Specificity, Limit of detection (LOD), Limit of Quantitation (LOQ), Pecision, Linearity, Accuracy ,Solution stability and Robustness. This method could be used to determination of sumatriptane succinate  in bulk and  pharmaceutical  tablet dosage forms.\",\"PeriodicalId\":13780,\"journal\":{\"name\":\"International Journal of Chemical and Pharmaceutical Analysis\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Chemical and Pharmaceutical Analysis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.20902/ijctr.2018.110502\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Chemical and Pharmaceutical Analysis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.20902/ijctr.2018.110502","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 1

摘要

建立了一种简便、准确的质子核磁共振(qNMR)定量测定片中琥珀酸舒马普坦含量的新方法。在本发明的定量核磁共振波谱法中,由于与被分析物峰不重叠,以马来酸为内标,以氧化氘(D2O)为稀释剂。琥珀酸舒马匹坦的定量以4.43 ppm和6.20 ppm的峰为定量监测目的,分别对应分析物琥珀酸舒马匹坦和马来酸内标。最终优化的方法按照国际激素会议(ICH)指南在特异性、检出限(LOD)、定量限(LOQ)、精密度、线性、准确性、溶液稳定性和鲁棒性方面进行了验证。该方法可用于琥珀酸舒马匹坦散装和片剂的含量测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
QUANTITATIVE NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION OF SUMATRIPTAN SUCCINATE IN PHARMACEUTICAL TABLET DOSAGE FORM
A new, simple and accurate quantitative proton nuclear magnetic resonance(qNMR) spectroscopic  method was developed to determine the sumatriptan succinate in pharmaceutical tablet formulation. In this developed quantitative nuclear magnetic resonance spectroscopy method,Maleic acid was used as internal standard(IS) due to there was no overlapping of the peak  to analyte peaks and deuterium oxide(D2O) was used as diluent. For the quantification of the sumatriptan succinate 4.43 ppm and 6.20 ppm  peaks were used as quantitative monitoring purpose to correspong to analyte sumatriptane succinate and Maleic acid internal standard(IS) respectively. The final optimized  method was validated as per International Conference on Hormonisation (ICH) guidelines in terms  of Specificity, Limit of detection (LOD), Limit of Quantitation (LOQ), Pecision, Linearity, Accuracy ,Solution stability and Robustness. This method could be used to determination of sumatriptane succinate  in bulk and  pharmaceutical  tablet dosage forms.
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
自引率
0.00%
发文量
0
×
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
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
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 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信