摘要
目的:建立一种高效液相色谱法,用于测定头孢克肟片中的有关物质.方法:采用Welch XB C18色谱柱(4.0 mm×125 mm,5 µm),四丁基氢氧化铵溶液∶乙腈(V四丁基氢氧化铵溶液∶V乙腈=75∶25)为流动相A,乙腈为流动相B,采用梯度洗脱程序;柱温为40℃;检测波长为254 nm;流速为1.0 mL/min.结果:该方法专属性良好,头孢克肟与各杂质峰之间的分离度良好,在各自浓度范围内,头孢克肟及5种杂质溶液浓度和峰面积呈良好的线性关系(r≥0.999 9);定量限、检出限、耐用性等均符合要求.结论:该方法可简便、快速、有效检出头孢克肟片中有关物质.
Abstract
Objective:To establish a HPLC method for the determination of related substances in cefixime tablets.Methods:The analytical column was Welch XB C18(4.0 mm×125 mm,5 pm),mobile phase A was tetrabutylammonium hudroxide solution-acetontrile(75∶25,volume ratio),mobile phase B was acetonitrile,gradient elution.The column temperature was 40 ℃,the detective wavelength was 254 nm,and the flow rate was about 1.0 mL/min.Results:The method had good specificity,and the separation degree between cefixime and each impurity peak is fine.In the respective concentration range,the concentration of cefixime and 5 impurity solutions has a good linear relationship with the peak area(r ≥0.999 9).Quantitative limits,detection limits,durability,etc all meet the requirements.Conclusion:The method is simple,rapid and effective for the detection of related substances in cefixime tablets.
维普
万方数据