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目的:建立盐酸阿扎司琼氯化钠注射液中二氯对二甲苯二聚体含量的HPLC测定方法。方法:采用Zorbax Extend C_(18)(4.6 mm×150 mm,5μm)柱,对二氯对二甲苯二聚体成分进行定量分析;采用乙腈-水(80∶20)等度洗脱;检测波长为228 nm;流速为1.5 mL/min。结果:主成分二聚体色谱峰与供试品中其他成分色谱峰间能达到基线分离;测得二氯对二甲苯二聚体的含量为0.003%。结论:建立的HPLC法选择性和灵敏度较高,可作为二聚体含量测定的方法。
OBJECTIVE: To establish a HPLC method for the determination of dichloro-p-xylene dimer in injection of azaserine hydrochloride and sodium chloride. Methods: The components of dichloro-p-xylene dimer were quantitatively analyzed by Zorbax Extend C_ (18) (4.6 mm × 150 mm, 5 μm) column, eluted with isocratic elution of acetonitrile-water 228 nm; flow rate 1.5 mL / min. Results: The main component dimer peak can be separated from other chromatographic peaks in the test sample. The content of dichloro paraxylene dimer was 0.003%. Conclusion: The established HPLC method has high selectivity and sensitivity and can be used as a method for the determination of dimer content.