采用气相色谱-质谱(GC-MS)对注射用谷胱甘肽中荧蒽进行分析方法验证  

The Analytical Method for the Detection of Fluoranthrene in Injectable Glutathione was Validated using Gas Chromatography-mass Spectrometry(GC-MS)

作　　者：黎芷明 王福坚 黄子健 周小琴 王涌杰 黄泽丹 王小婷 张铭儒 吴映晖 Li Zhiming;Wang Fujian;Huang Zijian;Zhou Xiaoqin;Wang Yongjie;Huang Zedan;Wang Xiaoting;Zhang Mingru;Wu Yinghui(Guangzhou Baiyunshan Mingxing Pharmaceutical Co.,Ltd.,Guangzhou 510000,China)

机构地区：[1]广州白云山明兴制药有限公司,广东广州510000

出　　处：《广东化工》2023年第23期124-126,共3页Guangdong Chemical Industry

摘　　要：采用气相色谱-质谱(GC-MS)对注射用谷胱甘肽(规格:0.3 g)中荧蒽进行分析方法验证。验证指标有:专属性、线性、定量限、准确度、精密度(重复性和中间精密度)、溶液稳定性和耐用性。本试验中所有验证指标的结果均满足接受标准的要求。The validation of an analytical method for the detection of fluoranthrene in injectable glutathione(0.3 g)was performed using gas chromatography-mass spectrometry(GC-MS).The validation parameters included specificity,linearity,quantitation limit,accuracy,precision(repeatability and intermediate precision),solution stability,and durability.The results of all validation parameters in this study met the acceptance criteria.

关 键 词：气相色谱-质谱 注射用谷胱甘肽 荧蒽测定 分析检验 分析方法验证 

分 类 号：TQ[化学工程]