Determination of Benzyl Chloride and Benzyl Dichloride in Fulvestrant Injection by GC-MS
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-lms capillary column(0.25 mm×30 m×0.25 μm)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.
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