摘要
采用LC-MS/MS法对注射用多西他赛中的有关物质进行鉴定。采用乙酸乙酯提取注射剂,以去除制剂中影响LC-MS/MS离子化效果的磺丁基-β-环糊精等辅料,然后对提取物中的有关物质进行LC-MS/MS鉴定。采用LC-ESI-MS/MS测定各有关物质的一级和二级质谱图,并对准分子离子的各个产物离子进行归属,对各杂质可能的结构进行推测。在所建立的条件下,多西他赛及其有关物质分离良好,共鉴定了注射用多西他赛中的9个有关物质结构,其中4个有关物质为首次在注射用多西他赛中发现。本文所建立的LC-MS/MS法可以有效地分离分析多西他赛及其有关物质,为其制剂的质量控制和工艺优化提供参考。
The related substances in docetaxel injection were identified by LC-MS/MS.Ethyl acetate was used to extract the injection to remove the pharmaceutical excipients.HPLC separation was carried out on a Hedera ODS-2 column（150 mm × 2.1 mm,5 μm） with a mobile phase consisting of acetonitrile - 0.1% acetate acid aqueous solution（40∶60）.Electrospray ionization source was set in the positive mode for the LC-ESI-MS/MS,and the ion monitoring modes were full scan and product ion scan.According to the mass spectra of the related substances,the fragment profiles were explained,and the chemical structures were elucidated.Docetaxel and its main related substances were well separated.Nine related substances in docetaxel injection were detected by LC-MS/MS.Their chemical structures were proposed,and four of them were identified in the docetaxel injection for the first time.The established LC-MS/MS method is effective in the separation and identification of the related substances in docetaxel injection.The test results are useful for its quality control.
出处
《药学学报》
CAS
CSCD
北大核心
2012年第6期779-784,共6页
Acta Pharmaceutica Sinica
