建立了一种有效的反相高效液相色谱法测定卡格列净原料药和制剂的含量

Vijayalakshmi Marella, Aisha J Syed, M. Lakshmiprasanna, B. N. Nalluri
{"title":"建立了一种有效的反相高效液相色谱法测定卡格列净原料药和制剂的含量","authors":"Vijayalakshmi Marella, Aisha J Syed, M. Lakshmiprasanna, B. N. Nalluri","doi":"10.7439/IJAPA.V7I3.4350","DOIUrl":null,"url":null,"abstract":"The objective of the present study was to develop a simple, specific and accurate reverse phase high performance liquid chromatographic method for the determination of Canagliflozin in bulk and pharmaceutical dosage forms. The method is optimized on an inertsil ODS-3(250.6mm, 5) column with a mobile phase combination of 0.02% Formic acid: Acetonitrile (40:60) at a flow rate 1.2ml/min and the eluents were monitored at 230nm. Under these LC conditions Canagliflozin peak was eluted at 4.4 min. The developed method was validated as per ICH guidelines. The calibration curve was linear over a concentration range of 10-50g/ml (R 2 =0.999) and the mean percentage assay was found to be 98.2. The statistical data proved that proposed method is accurate, precise and reproducible. The method which is LC-MS compatible can be adopted in the routine analysis of Canagliflozin in bulk and pharmaceutical dosage forms.","PeriodicalId":14317,"journal":{"name":"International Journal of Pharmaceutical Chemistry","volume":"1 1","pages":"24-27"},"PeriodicalIF":0.0000,"publicationDate":"2017-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"9","resultStr":"{\"title\":\"A novel validated RP-HPLC method for the estimation of canagliflozin in bulk and pharmaceutical dosage forms\",\"authors\":\"Vijayalakshmi Marella, Aisha J Syed, M. Lakshmiprasanna, B. N. Nalluri\",\"doi\":\"10.7439/IJAPA.V7I3.4350\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The objective of the present study was to develop a simple, specific and accurate reverse phase high performance liquid chromatographic method for the determination of Canagliflozin in bulk and pharmaceutical dosage forms. The method is optimized on an inertsil ODS-3(250.6mm, 5) column with a mobile phase combination of 0.02% Formic acid: Acetonitrile (40:60) at a flow rate 1.2ml/min and the eluents were monitored at 230nm. Under these LC conditions Canagliflozin peak was eluted at 4.4 min. The developed method was validated as per ICH guidelines. The calibration curve was linear over a concentration range of 10-50g/ml (R 2 =0.999) and the mean percentage assay was found to be 98.2. The statistical data proved that proposed method is accurate, precise and reproducible. The method which is LC-MS compatible can be adopted in the routine analysis of Canagliflozin in bulk and pharmaceutical dosage forms.\",\"PeriodicalId\":14317,\"journal\":{\"name\":\"International Journal of Pharmaceutical Chemistry\",\"volume\":\"1 1\",\"pages\":\"24-27\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-09-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"9\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Pharmaceutical Chemistry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.7439/IJAPA.V7I3.4350\",\"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 Pharmaceutical Chemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.7439/IJAPA.V7I3.4350","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 9

摘要

本研究的目的是建立一种简便、特异、准确的反相高效液相色谱法测定原料药和制剂中加格列净的含量。色谱柱为ODS-3(250.6mm, 5),流动相为0.02%甲酸:乙腈(40:60),流速为1.2ml/min,流速为230nm。在此LC条件下,在4.4 min洗脱Canagliflozin峰。所建立的方法按照ICH指南进行了验证。在10 ~ 50g/ml的浓度范围内,校正曲线呈线性(r2 =0.999),平均百分率为98.2%。统计数据证明了该方法的准确性、精密度和可重复性。本方法与LC-MS兼容,可用于卡格列净原料药和制剂制剂的常规分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A novel validated RP-HPLC method for the estimation of canagliflozin in bulk and pharmaceutical dosage forms
The objective of the present study was to develop a simple, specific and accurate reverse phase high performance liquid chromatographic method for the determination of Canagliflozin in bulk and pharmaceutical dosage forms. The method is optimized on an inertsil ODS-3(250.6mm, 5) column with a mobile phase combination of 0.02% Formic acid: Acetonitrile (40:60) at a flow rate 1.2ml/min and the eluents were monitored at 230nm. Under these LC conditions Canagliflozin peak was eluted at 4.4 min. The developed method was validated as per ICH guidelines. The calibration curve was linear over a concentration range of 10-50g/ml (R 2 =0.999) and the mean percentage assay was found to be 98.2. The statistical data proved that proposed method is accurate, precise and reproducible. The method which is LC-MS compatible can be adopted in the routine analysis of Canagliflozin in bulk and pharmaceutical 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