Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug

doi:10.1016/j.jpba.2018.03.054

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	Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug
	Liu, Xue-Wei 1,2; Zhang, Wen-Peng 1,2; Han, Hai-Yun 1; Sun, Ling 1; Chen, Dong-Ying1,2
刊名	JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
	2018-06-05
卷号	155 页码:104-108
关键词	Mutagenic impurities Alkyl toluenesulfonate Derivatization Headspace GC/MS
ISSN号	0731-7085
DOI	10.1016/j.jpba.2018.03.054
文献子类	Article
英文摘要	This study aims to optimize sodium iodide (Nal) derivatization headspace-GC/MS described in European Pharmacopoeia by using vitamin C as an alternative antioxidant for the determination of mutagenic alkyl toluenesulfonate impurities in an active pharmaceutical ingredient (API) of a candidate drug with an artemisinin derivative. Alkyl toluenesulfonates are transformed into their corresponding alkyl iodides (methyl iodide, ethyl iodide, propyl iodide, and isopropyl iodide) by utilizing the derivatization reagent Nal. Results show that the MS response of methyl iodide is a critical indicator of method robustness because of the deteriorating effects of methyl iodide on stability when sodium thiosulfate is used as an antioxidant originally described in the pharmacopoeia. With vitamin C as a newly developed antioxidant, the robustness of this method is improved significantly. The optimized method is further validated and applied successfully for the quality control and safety of the API of an artemisinin derivative. (C) 2018 Elsevier B.V. All rights reserved.
资助项目	Shanghai Institute of Materia Medica, Chinese Academy of Sciences for Innovative Pharmaceutical Project[CASIMM0120163011]
WOS关键词	ESTER GENOTOXIC IMPURITIES ; MASS-SPECTROMETRY ; GAS-CHROMATOGRAPHY ; SULFONATE ; SUBSTANCE ; ACID ; MS
WOS研究方向	Chemistry ; Pharmacology & Pharmacy
语种	英语
出版者	ELSEVIER SCIENCE BV
WOS记录号	WOS:000433267700012
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/279715]
专题	药物质量控制与固体化学研究中心
通讯作者	Chen, Dong-Ying
作者单位	1.Chinese Acad Sci, Shanghai Inst Mat Med, Lab Pharmaceut Anal, 555 Rd Zuchongzhi,Zhangjiang Hitech Pk, Shanghai 201203, Peoples R China; 2.Univ Chinese Acad Sci, 19A Yuquan Rd, Beijing 100049, Peoples R China
推荐引用方式 GB/T 7714	Liu, Xue-Wei,Zhang, Wen-Peng,Han, Hai-Yun,et al. Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,2018,155:104-108.
APA	Liu, Xue-Wei,Zhang, Wen-Peng,Han, Hai-Yun,Sun, Ling,&Chen, Dong-Ying.(2018).Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug.JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,155,104-108.
MLA	Liu, Xue-Wei,et al."Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 155(2018):104-108.