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目的:建立高效液相色谱法测定三磷酸胞苷二钠氯化钠注射液的有关物质方法。方法:色谱柱为Phenomenex LunaC_(18)(150 mm×4.60mm,5μm),以枸橼酸钠盐缓冲液(枸橼酸9.76 g,枸橼酸钠1.03 g,加水900 ml溶解,调pH至3.0,加入10%四丁基氢氧化铵2.5 ml,加水至1 000 ml)为流动相,流速1.0 ml·min~(-1),柱温25℃,检测波长为280nm。结果:杂质峰与主峰能够得到有效的分离,三批三磷酸胞苷二钠氯化钠注射液经检测有关物质分别为7.6%、7.9%、7.3%。结论:该法可用于检查三磷酸胞苷二钠氯化钠注射液中的有关物质,简便、快速、准确。
Objective: To establish a HPLC method for the determination of related substances in cytidine disodium sodium chloride injection. METHODS: Phenomenex LunaC_ (18) (150 mm × 4.60 mm, 5 μm) was used as the chromatographic column. Sodium citrate buffer solution (citric acid 9.76 g, sodium citrate 1.03 g, 3.0, add 10% tetrabutylammonium hydroxide 2.5 ml, add water to 1000 ml) as the mobile phase at a flow rate of 1.0 ml · min -1. The column temperature is 25 ℃ and the detection wavelength is 280 nm. Results: The impurity peak and the main peak can be effectively separated. The contents of the tested batches of three batches of cytidine triphosphate disodium sodium chloride injection were 7.6%, 7.9% and 7.3% respectively. Conclusion: This method can be used to check the related substances in cytidine disodium sodium chloride injection, which is simple, rapid and accurate.