Determination of Two Alkyl Chlorides in Cetirizine Dihydrochloride by Gas Chromatography-mass Spectrometry
A gas chromatography-mass spectrometry(GC-MS)method was established for two genotoxic alkyl chloride impurities,namely 4-chloro-4-methylpentan-2-one(2)and 2,6-dichloro-2,6-dimethyl-4-heptanone(3),in cetirizine dihydrochloride(1).The VF-WAXms capillary column(0.25 mm×30 m×0.25 μm)was used,and the measurement was performed in selected ion monitoring(SIM)mode.The results showed that it was linear for 2 and 3 in the ranges of 75.86-455.16 ng/mL and 75.18-451.08 ng/mL.The limits of quantification were 0.025 and 0.066 ng/mL,respectively.Tthe recoveries were 101.66％and 102.46％,respectively.The established method can determine 2 and 3 in 1,which provide a reference for the quality study of 1.
gas chromatography-mass spectrometrycetirizine dihydrochloride4-chloro-4-methylpentan-2-one2,6-dichloro-2,6-dimethyl-4-heptanonegenotoxic impurity
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