摘要
目的:建立以高效液相色谱法测定硫辛酸注射液中有关物质及其含量的方法。方法:色谱柱为ShimpackCLC-ODS(5μm,150.0mm×4.6mm)不锈钢柱,流动相为乙腈—0.005mo1/L磷酸二氢钾溶液(50∶50,用磷酸调pH为3.0),流速为1.0ml/min,进样量为20μl,检测波长为212nm。结果:硫辛酸进样量在0.81～8.10μg的范围内线性关系良好(r=0.999);平均回收率为99.17%(RSD=0.40%)。结论:本方法简便、准确,可用于硫辛酸注射液的有关物质及其含量的测定。
Objective： Establish HPLC method to determinate of lipoic acid injection and the related substances. Methods： The column used octadecyl silane bonded silica as a filler, particle size 5 μm, column size： 150.0 mm×4.6 mm, stainless steel column. Mobile phase was acetonitrile and 0.005 mol/L phosphate potassium solution （v：v=50：50, pH 3.0 with phosphoric acid）, flow rate was 1.0 ml/min, injection volume was 20 μl, the detection wavelength was 212 nm. Results： The linear range of detection of concentration of lipoic acid was 0.81～8.10 μg （r=0.999）; the average recovery was 99.17% （RSD=0.40%）; Conclusion： This method is simple and accurate, can be used for the determination of related substances of lipoic acid injection.
出处
《中国当代医药》
2010年第35期44-45,共2页
China Modern Medicine
