摘要
目的：建立RP-HPLC法测定维生素C粉针剂中维生素C和有关物质的含量。方法：采用的色谱柱为Phenomenex luna氨基柱（5μm,4.6mm×250mm）,柱温25℃,流动相为0.02mol.L-1的磷酸二氢钾液（pH=3.0）和乙腈的混合液（体积比1∶1）,系统流速1.0mL.min-1,检测波长为245nm。结果：该方法的线性范围为5.0~30.0μg.mL-1,标准曲线的相关系数为0.999 5;日内和日间精密度的RSD分别小于0.53%、2.98%;平均加样回收率（n=9）为99.12%,RSD=2.44%。结论：此法灵敏度高,结果准确,重现性好,可有效控制维生素C粉针剂的质量。
Objective：To develop the RP-HPLC method for the quantitative analysis of main component and related substances in vitamin C powder injection.Methods：The liquid chromatography was carried out using a NH2 column（5μm,4.6×250mm） with detection wavelength at 245nm.The mobile phase as follows：acetonitrile-dibasic potassium phosphate buffer solution（0.02mol.L-1,pH=3.0）=1∶1.The flow rate was 1mL·min-1,and column temperature was at 25℃.Results：The calibration curve was linear in the range of 5.0~30.0μg·mL-1,r=0.999 5.Average recovery（n=9） was 99.12%,RSD=2.44%.RSD of inter-day and within-day precision was less than 0.53% and 2.98% respectively.Conclusion：This method was found to be sensitive,and accurate for the quality control of vitamin C powder injection.
出处
《亚太传统医药》
2011年第9期37-38,共2页
Asia-Pacific Traditional Medicine
