建立高效液相色谱法测定奥硝唑片有关物质和含量的方法学研究

The Establishment of High-performance Liquid Chromatography Ornidazole Tablets Substance and Content of the Relevant Methodological Studies

目的:建立HPLC法测定奥硝唑片的有关物质和含量。方法:采用高效液相色谱仪,以甲醇-水为流动相,采用不同色谱条件及进样速度对奥硝唑对照品进行检测,考察关物质检测的稳定性、可重复性及可靠性。结果:检测波长为318nm,有关物质进样量在13.3～212.9μ g/ml范围内线性关系良好,r=0.9999;含量测定进样量在25.7～411.2 μ g/ml范围内线性关系良好,r=0.9999,检测结果具有良好的。结论:HPLC在合适的色谱条件下,能够准确检测奥硝唑片有关物质及含量。

Objective：Establish the HPLC measurement of the relevant substance and the content of the omidazole tablets.Methods：To measure omidazole tablets and reference substance with HPLC in methanol ＆ water as the mobile phase,in different sample size and chromatographic condition ,to observe the stability, reliability, repeatability and reliability.Results：Determination of related substances in injection volume should be controlled between 13.3μg/ml and 212.9μg/ml which has the good linear relationship, r=0.9999. The measurement of the content in injection should be in the good relationship between 25.7μg/ml and 411.2μg/ml, r=0.9999,the record of detection keep good the stability, reliability, repeatability and reliability. Conclusions：HPLC could accuratly detect omidazole tablets＇ related substance and Omidazole＇s content in proper chromatographic condition.