A novel two-dimensional liquid chromatography - Mass spectrometry method for direct drug impurity identification from HPLC eluent containing ion-pairing reagent in mobile phases
文献类型：期刊论文
| 作者 | Zheng, Xin1; Huang, Taohong1; Long, Zhen1; Zhan, Zhaoqi3; Guo, Zhimou2; Li, Yueqi1; Yao, Jinting1; Ji, Feng1; Li, Changkun1; Ren, Biao1 |
| 刊名 | ANALYTICA CHIMICA ACTA
 |
| 出版日期 | 2019-02-21 |
| 卷号 | 1049页码:105-114 |
| ISSN号 | 0003-2670 |
| 关键词 | Two dimensional liquid chromatography Ion-pairing reagent Non-volatile Mass spectrometry Generic drug Impurity |
| DOI | 10.1016/j.aca.2018.10.031 |
| 通讯作者 | Guo, Zhimou(guozhimou@dicp.ac.cn) ; Li, Yueqi(fxlyq@shimadzu.com.cn) |
| 英文摘要 | In this study, a novel two dimensional liquid chromatography - mass spectrometry (2D-LC-MS) method with use of a weak anion exchange column between the 1st DLC RP column and the 2nd DLC RP column (RP1-WAX-RP2) was developed and applied to identify drug impurities from MS incompatible mobile phases containing sodium 1-octanesulfonate and non-volatile buffer. The 1st DLC conditions follow exactly the original standard HPLC method recorded in Chinese Pharmacopeia (ChP), European Pharmacopeia (EP) or US Pharmacopeia (USP). An impurity fraction was collected with a built-in sample loop (100 mu L) and transferred to the WAX column where 1-octanesulfonate and phosphate were trapped and removed. While, the impurity and other cations were eluted to the 2nd D column (RP2) for separation and identification by connected IT-TOF MS. Methods were programmed and applied to identify impurities in two generic drugs, sulpiride (hydrophilic drug with logP 0.57) and dobutamine (hydrophobic drug with logP 3.6). The results indicate that the methods based on RP1-WAX-RP2 column configuration offer a feasible solution for direct impurity identification in generic drug product or API without needs of off-line desalting from the MS incompatible mobile phases containing ion-pairing reagent and nonvolatile buffer. (C) 2018 Elsevier B.V. All rights reserved. |
| WOS关键词 | BASIC COMPOUNDS ; SEPARATION ; ALKALOIDS ; COLUMN ; RETENTION |
| WOS研究方向 | Chemistry |
| 语种 | 英语 |
| 出版者 | ELSEVIER SCIENCE BV |
| WOS记录号 | WOS:000454789100012 |
| 源URL | [http://cas-ir.dicp.ac.cn/handle/321008/166328]  |
| 专题 | 大连化学物理研究所_中国科学院大连化学物理研究所 |
| 通讯作者 | Guo, Zhimou; Li, Yueqi |
| 作者单位 | 1.Shimadzu Sci Instrument Co, Beijing 100020, Peoples R China 2.Chinese Acad Sci, Dalian Inst Chem Phys, Key Lab Separat Sci Analyt Chem, Dalian 116023, Peoples R China 3.Shimadzu Asia Pacific Pte Ltd, Singapore 118264, Singapore |
| 推荐引用方式 GB/T 7714 | Zheng, Xin,Huang, Taohong,Long, Zhen,et al. A novel two-dimensional liquid chromatography - Mass spectrometry method for direct drug impurity identification from HPLC eluent containing ion-pairing reagent in mobile phases[J]. ANALYTICA CHIMICA ACTA,2019,1049:105-114. |
| APA | Zheng, Xin.,Huang, Taohong.,Long, Zhen.,Zhan, Zhaoqi.,Guo, Zhimou.,...&Ren, Biao.(2019).A novel two-dimensional liquid chromatography - Mass spectrometry method for direct drug impurity identification from HPLC eluent containing ion-pairing reagent in mobile phases.ANALYTICA CHIMICA ACTA,1049,105-114. |
| MLA | Zheng, Xin,et al."A novel two-dimensional liquid chromatography - Mass spectrometry method for direct drug impurity identification from HPLC eluent containing ion-pairing reagent in mobile phases".ANALYTICA CHIMICA ACTA 1049(2019):105-114. |
入库方式： OAI收割
来源：大连化学物理研究所
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