HPLC法测定门冬氨酸洛美沙星葡萄糖注射液中5-HMF和有关物质

Determination of 5-HMF and Related Substances in Lomefloxacin Aspartate and Glucose Injection by HPLC

目的:本文采用HPLC法测定门冬氨酸洛美沙星葡萄糖注射液中5-羟甲基糠醛(5-HMF)和有关物质。方法:使用Welch Ultimate XB-C18(4.6 mm×250 mm,5μm)色谱柱,以0.67%磷酸二氢钾溶液-甲醇(76∶24)(用磷酸调节pH值至2.7)为流动相A,乙腈为流动相B,梯度洗脱,在波长287 nm检测。结果:5-HMF和杂质均得到良好分离,方法专属性较好。5-HMF浓度在0.48~19.20μg·mL^-1范围内有线性关系良好(r^2=0.9995),洛美沙星浓度在1.97~394μg·mL^-1范围内有线性关系良好(r^2=0.9995)。结论:建立的5-HMF和有关物质检测方法可用于门冬氨酸洛美沙星葡萄糖注射液的质量控制。

Objective:To establish suitable HPLC method for determination of 5-hydroxymethylfurfural(5-HMF)and related substances in Lomefloxacin aspartate and glucose injection.Methods:Welch Ultimate XB-C18(4.6 mm×250 mm,5μm)column was used.0.67%potassium dihydrogen phosphate solution-methanol(76∶24)(pH adjusted to 2.7 by phosphoric acid)was used as mobile phase A,and acetonitrile was used as mobile phase B.Gradient elution was performed and detection wavelength was 287nm.Results:Both 5-HMF and impurities were well separated,and the method had good specificity.5-HMF showed a good linear relationship at a range of 0.48-19.20μg·mL^-1(r^2=0.9995),and lomefloxacin showed a good linear relationship at a range of 1.97-394μg·mL^-1(r^2=0.9999).Conclusion:The method for the determination of 5-HMF and related substances can be used for the quality control of lomefloxacin aspartate and glucose injection.