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A novel two-dimensional liquid chromatography - Mass spectrometry method for direct drug impurity identification from HPLC eluent containing ion-pairing reagent in mobile phases
Long, Zhen1; Zhan, Zhaoqi2; Guo, Zhimou3; Li, Yueqi1; Yao, Jinting1; Ji, Feng1; Li, Changkun1; Zheng, Xin1; Ren, Biao1; Huang, Taohong1
Corresponding AuthorGuo, Zhimou(guozhimou@dicp.ac.cn) ; Li, Yueqi(fxlyq@shimadzu.com.cn)
KeywordTwo dimensional liquid chromatography Ion-pairing reagent Non-volatile Mass spectrometry Generic drug Impurity
Source PublicationANALYTICA CHIMICA ACTA
2019-02-21
ISSN0003-2670
DOI10.1016/j.aca.2018.10.031
Volume1049Pages:105-114
WOS SubjectChemistry, Analytical
WOS Research AreaChemistry
WOS KeywordBASIC COMPOUNDS ; SEPARATION ; ALKALOIDS ; COLUMN ; RETENTION
AbstractIn 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.
Language英语
WOS IDWOS:000454789100012
PublisherELSEVIER SCIENCE BV
Citation statistics
Document Type期刊论文
Identifierhttp://cas-ir.dicp.ac.cn/handle/321008/166329
Collection中国科学院大连化学物理研究所
Corresponding AuthorGuo, Zhimou; Li, Yueqi
Affiliation1.Shimadzu Sci Instrument Co, Beijing 100020, Peoples R China
2.Shimadzu Asia Pacific Pte Ltd, Singapore 118264, Singapore
3.Chinese Acad Sci, Dalian Inst Chem Phys, Key Lab Separat Sci Analyt Chem, Dalian 116023, Peoples R China
Recommended Citation
GB/T 7714
Long, Zhen,Zhan, Zhaoqi,Guo, Zhimou,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 Long, Zhen.,Zhan, Zhaoqi.,Guo, Zhimou.,Li, Yueqi.,Yao, Jinting.,...&Huang, Taohong.(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 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".ANALYTICA CHIMICA ACTA 1049(2019):105-114.
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