Determination of genotoxic impurities in tosufloxacin tosylate hydrate by GC-MS-MS
10.19778/j.chp.2025.04.009
- VernacularTitle:GC-MS-MS法测定甲苯磺酸妥舒沙星中基因毒性杂质
- Author:
Hongyu CHEN
1
;
Xueqing CHENG
;
Lirong CAI
;
Yanming LIU
;
Jinfeng ZHENG
;
Feicheng PENG
;
Lei FAN
Author Information
1. 湖南省药品检验检测研究院,湖南省药品质量评价工程技术研究中心,国家药品监督管理局药用辅料工程技术研究重点实验室,长沙 410001
- Publication Type:Journal Article
- Keywords:
GC-MS-MS;
tosufloxacin tosylate hydrate;
genotoxic impurities;
methyl p-toluenesulfonate;
ethyl p-tolu-enesulfonate;
isopropyl p-toluenesulfonate
- From:
Drug Standards of China
2025;26(4):393-398
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a gas chromatography-mass spectrometry method(GC-MS-MS)for determining the content of methyl p-toluenesulfonate(MTS),ethyl p-toluenesulfonate(ETS),and isopropyl p-toluenesulfonate(IPTS)in tosufloxacin tosylate hydrate.Methods:The HP-1MS(0.250 mm ×30 m,0.50 μm)column was used at progamming temperature,the injection temperature was 250 ℃.The MS conditions were as follow:the ionization mode was EI,the electron voltage was 70 V,the ion source temperature was 250 ℃,the scanning method was MRM,the quantitative ion pairs for MTS,ETS and IPTS were m/z 91 →65,m/z 155→91 and m/z 91→65.Results:The linearity ranges of MTS,ETS and IPTS were 48.779-975.59 ng·mL-1(r=0.998 5),54.586-1 091.7 ng·mL-1(r=0.998 4)and 46.241-924.82 ng·mL-1(r=0.999 8).The average recoveries were 99.47％,99.15％,98.83％(n=9).The MTS,ETS and IPTS were not detected in the 7 batches of tosufloxacin tosylate hydrate.Conclusion:The established method can be used for the determination of MTS,ETS,and IPTS content in tosufloxacin tosylate hydrate.
