摘要
建立了气相色谱-质谱(GC-MS)法测定氟维司群注射液(1)中的遗传毒性杂质氯化苄(2)、二氯化苄(3)。采用VF-1ms毛细管柱(0.25mm×30m×0.25μm),采用2种监测模式,分别对2(MRM)与3(SIM)进行测定。结果显示,2和3分别在5.427~54.272、4.775~47.748 ng/mL内线性关系良好,定量限分别为2.714、2.387 ng/mL,检测限分别为0.54、0.48ng/mL,平均回收率(n=9)分别为99.43%、99.09%,RSD分别为2.43%、2.66%。建立的GC-MS法可为1中的杂质研究提供参考。
A gas chromatography-mass spectrometry(GC-MS)method was established to determine the genotoxic impurities of benzyl chloride(2)and benzyl dichloride(3)in fulvestrant injection(1).The VF-1ms capillary column(0.25 mm×30 m×0.25μm)was used,and two monitoring modes were respectively adopted to measure 2(MRM)and 3(SIM).The results showed that it was linear for 2 and 3 in the ranges of 5.427-54.272 ng/mL,4.775-47.748 ng/mL,respectively.The LOQs of 2 and 3 were 2.714 and 2.387 ng/mL,and the LODs were 0.54 and 0.48 ng/mL,respectively.The average recoveries(n=9)of 2 and 3 were 99.43%and 99.09%,with the RSDs of 2.43%and 2.66%,respectively.The established GC-MS method can provide references for impurity research in 1.
作者
郑华
卢红华
何艳琴
郝贵周
张贵民
ZHENG Hua;LU Honghua;HE Yanqin;HAO Guizhou;ZHANG Guimin(National Chiral Pharmaceuticals Engineering and Technology Research Center,Lunan Pharmaceutical Group Co.,Ltd.,Linyi 273400)
出处
《中国医药工业杂志》
EI
CAS
CSCD
2024年第2期283-286,共4页
Chinese Journal of Pharmaceuticals
