HPLC法测定复方苦参注射液中5-羟甲基糠醛的含量

Determination of 5-Hydroxymethylfurfural in Compound Kushen Injection(CKI)by HPLC

目的:建立复方苦参注射液中5-羟甲基糠醛(5-HMF)含量的测定方法。方法:采用高效液相色谱法,色谱柱为Waters XSelect CSH TM C 18(250 mm×4.6 mm,5μm),流动相为甲醇-0.05%甲酸水溶液梯度洗脱,流速为0.8 mL·min^(-1),检测波长为284 nm,柱温20℃,进样量10μL。结果:5-HMF质量浓度在0.022~1.11μg(r=0.9998)范围内质量呈良好线性关系。5-HMF平均回收率为95.6%(RSD=6.70%)(n=9)。结论:本研究方法重复性好,准确度高,可用于复方苦参注射液中5-HMF的含量测定。

Objective To establish a method for the determining the content of 5-hydroxymethylfurfural in Compound Kushen Injection(CKI).Methods High performance liquid chromatography was utilized with Waters XSelect CSH^(TM)C_(18)(250 mm×4.6 mm,5μm)chromatographic column,and mobile phase of acetonitrile-0.05%formic acid aqueous solution was used for gradient elution at the flow rate was 0.8 mL·min^(-1).The detection wavelength was 284 nm;column temperature was 20℃;injection volume 20μL.Results The calibration curve of 5-hydroxymethylfurfural showed good linearity within the range of 0.02~1.11μg·mL^(-1).The average recovery of 5-HMF(n=9)was 95.6%with RSD of 6.70%.Conclusion The proposed method was accurate and reproducible enough to be used for the content determination of 5-hydroxymethylfurfural in CKI.