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目的:建立HPLC测定葡萄糖氯化钠注射液(250 m L:葡萄糖12.5 g与氯化钠2.25 g)中2,4-二叔丁基苯酚(168降解产物)含量测定方法。方法:采用Eclipse C_(18)色谱柱,以乙腈-水(70∶30)为流动相,检测波长为210 nm。结果:抗氧剂168降解产物0.1~50μg·m L~(-1)范围内线性关系良好,回收率为94%~100%,RSD小于0.8%。样品实测结果均小于0.01μg·m L~(-1)。结论:固相萃取-高效液相色谱法测定抗氧剂168降解产物在葡萄糖氯化钠注射液中含量的测定方法准确可靠。
OBJECTIVE: To establish a method for the determination of 2,4-di-tert-butylphenol (168 degradation product) in glucose and sodium chloride injection (250 m L: glucose 12.5 g and sodium chloride 2.25 g) Methods: Eclipse C 18 column with acetonitrile-water (70:30) as mobile phase was used. The detection wavelength was 210 nm. Results: The linear relationship was found between 0.1 and 50 μg · m L -1 of antioxidant 168, with a recovery of 94% -100% and a RSD of less than 0.8%. The measured results were less than 0.01μg · m L -1. Conclusion: The method for determination of antioxidant 168 degradation products in glucose and sodium chloride injection by solid phase extraction - high performance liquid chromatography is accurate and reliable.