高效液相色谱法分析胞磷胆碱钠与葡萄糖配伍注射液在不同输液器具中的稳定性

Analysis of stability of citicoline sodium and glucose combined injection in different influsion devices by high performance liquid chromatography

建立高效液相色谱法测定胞磷胆碱钠与10%葡萄糖配伍注射液中5-羟甲基糠醛含量,并将其用于配伍溶液在不同输液器具中的稳定性研究。胞磷胆碱钠与10%葡萄糖配伍注射液,采用Thermo Scientific BDS HypersilTM C18色谱柱(250 mm×4 mm,5μm)分离,柱温为40℃,以10 mmol/mL四丁基氢氧化铵-15 mmol/mL磷酸氢二钠溶液(用20%磷酸调pH值至6.0)-甲醇作为流动相进行梯度洗脱。进样体积为15μL,检测波长为284 nm。5-羟甲基糠醛在0.02~54.09μg/mL质量浓度范围内线性关系良好(r=0.9999)。方法定量限为0.02μg/mL,检出限为0.005μg/mL。样品加标回收率为99.5~100.6%,测定结果的相对标准偏差(RSD)为0.66%。配伍溶液在聚烯烃热塑弹性体(TPE)、聚氯乙烯(PVC)材质输液器具中8 h内,5-羟甲基糠醛质量分数的相对偏差均小于0.6%(n=6),胞磷胆碱钠质量分数相对偏差均小于2.8%。该方法操作简单、灵敏度高,适用于5-羟甲基糠醛含量及其配伍溶液稳定性研究。

A high performance liquid chromatography method for the determination of 5-hydroxymethylfurfural in citicoline sodium and 10%glucose combined injection was established and used to study the stability of the compatible solution in different infusion devices.The samples were citicoline sodium and 10%glucose combined injection and separated on Thermo Scientific BDS HypersilTMC18 column(250 mm×4 mm,5μm)at a column temperature of 40℃.Gradient elution was performed with 10 mmol/mL tetrabutylammonium hydroxide-15 mmol/mL disodium hydrogen phosphate solution(pH adjusted to 6.0 with 20%phosphoric acid)-methanol as the mobile phase.The sample volume was 15μL and the detection wavelength was 284 nm.The linear relationship of 5-hydroxymethylfurfural was good in the concentration range of 0.02μg/mL to 54.09μg/mL(r=0.9999).The limit of quantification was 0.02μg/mL and the limit of detection was 0.005μg/mL.Recovery rate of samples were 99.5%-100.6%,and the relative standard deviation(RSD)of the measurement results was 0.66%.The compatible injection was in the infusion devices made of polyolefin thermoplastic elastomer(TPE)or polyvinyl chloride(PVC)for 8 h,the relative deviation of 5-hydroxymethylfurfural mass fraction were all less than 0.6%(n=6).The relative deviation of citicoline sodium mass fraction were all less than 2.8%.The established method is simple and sensitive,and is suitable for the study of 5-hydroxymethylfurfural content and the stability of its compatible solution.