高效液相色谱法测定肠内营养混悬液中维生素C含量  

Content Determination of Vitamin C in Enteral Nutritional Suspension by HPLC

作　　者：金舒 申兰慧 JIN Shu;SHEN Lanhui(Jiangsu Wuxi Institute of Drug Control,Wuxi,Jiangsu,China 214028)

机构地区：[1]江苏省无锡市药品安全检验检测中心,江苏无锡214028

出　　处：《中国药业》2024年第13期90-92,共3页China Pharmaceuticals

基　　金：江苏省市场监督管理局科技计划项目[KJ2022029]。

摘　　要：目的建立测定肠内营养混悬液中维生素C含量的高效液相色谱法。方法色谱柱为Acutfex YS-NH_(2)柱(250 mm×4.6 mm,5µm),流动相为甲醇-1%枸橼酸水溶液(80∶20,V/V),流速为1.0 mL/min,检测波长为254 nm,柱温为30℃,进样量为10µL。结果维生素C的质量浓度在1.01~20.16µg/mL范围内与峰面积线性关系良好(r=0.9995,n=6);检测限为0.13 ng/mL,定量限为0.42 ng/mL;精密度、稳定性、重复性试验结果的RSD均小于2.0%(n=6);平均回收率为98.15%,RSD为1.34%(n=9)。5批样品中维生素C的含量为120.18~233.95µg/mL。结论该方法操作简便、结果准确、灵敏度高,可用于肠内营养混悬液中维生素C的含量测定。Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of vitamin C in Enteral Nutrition Suspension.Methods The chromatography column was Acutfex YS-NH_(2) column(250 mm×4.6 mm,5µm),the mobile phase was methanol-1%citric acid aqueous solution(80∶20,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 254 nm,the column temperature was 30℃,and the injection volume was 10µL.Results The linear range of vitamin C was 1.01-20.16µg/mL(r=0.9995,n=6),the limit of detection was 0.13 ng/mL,and the limit of quantification was 0.42 ng/mL.The RSDs of precision,stability,and repeatability test results were all lower than 2.0%(n=6).The average recovery of vitamin C was 98.15%with an RSD of 1.34%(n=9).The content of vitamin C in five batches of samples was in the range of 120.18-233.95µg/mL.Conclusion The method is simple,accurate,and highly sensitive,which can be used for the content determination of vitamin C in Enteral Nutrition Suspensions.

关 键 词：高效液相色谱法 肠内营养混悬液 维生素C 含量测定 

分 类 号：R927.2[医药卫生—药学] R977.2