OBJECTIVE To determine the 2-methoxyethoxymethyl chloride(MEM)by derivatization GC-MS method,a potentially genotoxic impurity in Roxithromycin.METHODS Isopropyl alcohol was used as both solvent and derivatization reagent.The derivative were separated by HP-5MS UI(30 m ×0.25 mm,0.25 μm),and determined by selected ion monitoring mode.RESULTS A good linear relationship was obtained between the peak areas and the concentrations of derivative of MEM chloride in the range of 2.412-19.30 ng·mL-1.The recoveries were 70.1％-90.4％,and the RSD was 9.30％(n=9).Limit of detection was 0.6 μg·g-1.MEM derivative was not detected in three batches of Roxithromycin samples.CONCLUSION The method is sensitive and specific,which can be used for the quality control of MEM in Roxithromycin.
维普
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