高效液相色谱法用于米格列奈钙含量和有关物质的研究

Research on HPLC Used in Determination of the Contents of Mitiglinide Calcium and Its Related Substances

目的:建立米格列奈钙的含量及有关物质的高效液相色谱测定方法。方法:采用Agilent SB-C18柱(250mm×4.6mm,5μm);流动相:水溶液(用磷酸调节pH值为2.4)-乙腈(55:45);检测波长为:210nm;流速:1mL/min;柱温:30℃。结果:建立的色谱方法是有关物质与主药分离良好,米格列奈钙在80μg/mL～120μg/mL范围内,r=0.9999,浓度与线性关系良好。结论:本法简便、准确,可用于米格列奈钙的含量测定及其有关物质的测定。

Aim： To develop a HPLC method for the determination of mitiglinide calcium and its related substances. Methods： The chromatography conditions were as follows： an Agilent SB-C 18 column （250 min×4.6 ram,5 μm）, the mobile phase was consisted of water （pH2.4 adjusted with H3PO4）-acetonitrile （55：45） with flow rate of 1.0 ml / min and the column temperature was 30~C. The detection wave-length was 210 nm. Result： There was a good linearity over the range of 80-120 μg/ml with a correlation coefficient r=0.999 9. Conclusion： The method was simple and accurate, which can be used for the quality control of mitiglinide calcium.