汉防己甲素含量和有关物质测定方法改进

Method Improvement for Assay and Related Substances of Tetrandrine

关键词:  高效液相色谱法  汉防己甲素  含量测定  有关物质

Key words:  HPLC  tetrandrine  content determination  related substances

摘要:

目的 使用高效液相色谱法，通过改进和优化汉防己甲素含量和有关物质测定的色谱条件，提高检测灵敏度和准确率。方法 色谱柱为Kromasil C₁₈柱(250 mm×4.6 mm，5 μm)，流动相为水-乙腈-三乙胺(650∶350∶3，用磷酸调pH至2.0)，流速为1 mL·min^-1，检测波长为280 nm，柱温为35 ℃。结果 汉防己甲素在50~350 μg·mL^-1内，峰面积与浓度呈良好的线性关系(r=0.999 9)，平均回收率99.8%，RSD=0.3%。汉防己甲素与相关物质分离良好。结论 采用改进后的方法，能快速准确地对汉防己甲素的含量和有关物质进行检测和控制，方法简便，可操作性好。

Abstract:

OBJECTIVE To optimize the chromatographic condition of HPLC method for tetrandrine and its related substances to improve the sensitivity and accuracy. METHODS A Kromasil C₁₈ column(250 mm×4.6 mm, 5 μm) was used with the column temperature of 35 ℃. The mobile phase was water-acetonitrile-triethylamine (650∶350∶3), adjusted to pH 2.0 with phosphoric acid, the flow rate was 1 mL·min^-1. The detector wavelength was 280 nm. RESULTS Tetrandrine had a good linearity in the range of 50-350 μg·mL^-1(r=0.999 9), the average recovery rate was 99.8% with RSD of 0.3%. Tetrandrine and related substances in the sample could be separated. CONCLUSION This improved method is more quick and accurate for determing the content and related substances in tetrandrine. The method is easy to be operated.