拉米夫定处方的反相高效液相色谱分析方法的建立与验证

Anshul Kumar, C. Majee, Vivek Namdev
{"title":"拉米夫定处方的反相高效液相色谱分析方法的建立与验证","authors":"Anshul Kumar, C. Majee, Vivek Namdev","doi":"10.20902/ijptr.2019.130201","DOIUrl":null,"url":null,"abstract":"Aim of the experiment was to develop a simple, specific and accurate reverse phase ultra-performance liquid chromatographic (UPLC) method for the determination of lamivudine in the tablet dosage forms. The chromatographic separation was achieved on Acquity UPLC HSST3 (2.1 x 100mm) 1.8 um particle size and the mobile phase containing 0.1%TFA: MeOH for lamivudine. The run time was 10 min and the retention time of lamivudine was about 4.6. The detection was carried out 215nm using photo diode array detector (PDA) with a flow rate 0.6 ml/min. The linearity of lamivudine with correlation coefficient 0.9998. The recovery was found in the range (100±10%). The developed method was validated as per International Conference on Harmonization guidelines (ICH) with respect to specificity, linearity, accuracy, method precision, system precision, solution stability and robustness.","PeriodicalId":14252,"journal":{"name":"International Journal of PharmTech Research","volume":"79 1","pages":"1-6"},"PeriodicalIF":0.0000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Analytical Method development and Validation of Lamivudine\\nin Formulation by using Reversed Phase Ultra Performance\\nLiquid Chromatography\",\"authors\":\"Anshul Kumar, C. Majee, Vivek Namdev\",\"doi\":\"10.20902/ijptr.2019.130201\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Aim of the experiment was to develop a simple, specific and accurate reverse phase ultra-performance liquid chromatographic (UPLC) method for the determination of lamivudine in the tablet dosage forms. The chromatographic separation was achieved on Acquity UPLC HSST3 (2.1 x 100mm) 1.8 um particle size and the mobile phase containing 0.1%TFA: MeOH for lamivudine. The run time was 10 min and the retention time of lamivudine was about 4.6. The detection was carried out 215nm using photo diode array detector (PDA) with a flow rate 0.6 ml/min. The linearity of lamivudine with correlation coefficient 0.9998. The recovery was found in the range (100±10%). The developed method was validated as per International Conference on Harmonization guidelines (ICH) with respect to specificity, linearity, accuracy, method precision, system precision, solution stability and robustness.\",\"PeriodicalId\":14252,\"journal\":{\"name\":\"International Journal of PharmTech Research\",\"volume\":\"79 1\",\"pages\":\"1-6\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of PharmTech Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.20902/ijptr.2019.130201\",\"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 PharmTech Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.20902/ijptr.2019.130201","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

本实验旨在建立一种简便、特异、准确的反相超高效液相色谱法测定拉米夫定片剂中拉米夫定的含量。拉米夫定采用Acquity UPLC HSST3 (2.1 × 100mm) 1.8 um粒度,0.1%TFA: MeOH为流动相进行色谱分离。运行时间为10 min,拉米夫定的保留时间约为4.6。采用光电二极管阵列检测器(PDA),流速0.6 ml/min,检测波长215nm。拉米夫定的线性相关系数为0.9998。回收率在(100±10%)范围内。根据国际协调会议指南(ICH)对所开发的方法进行了特异性、线性、准确性、方法精密度、系统精密度、溶液稳定性和鲁棒性的验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical Method development and Validation of Lamivudine in Formulation by using Reversed Phase Ultra Performance Liquid Chromatography
Aim of the experiment was to develop a simple, specific and accurate reverse phase ultra-performance liquid chromatographic (UPLC) method for the determination of lamivudine in the tablet dosage forms. The chromatographic separation was achieved on Acquity UPLC HSST3 (2.1 x 100mm) 1.8 um particle size and the mobile phase containing 0.1%TFA: MeOH for lamivudine. The run time was 10 min and the retention time of lamivudine was about 4.6. The detection was carried out 215nm using photo diode array detector (PDA) with a flow rate 0.6 ml/min. The linearity of lamivudine with correlation coefficient 0.9998. The recovery was found in the range (100±10%). The developed method was validated as per International Conference on Harmonization guidelines (ICH) with respect to specificity, linearity, accuracy, method precision, system precision, solution stability and robustness.
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