HPLC法测定头孢克肟片中的有关物质  

Determination of Related Substances in Cefixime Tablets by HPLC

作　　者：满彦汝 董娟 刘姣 程宁宁 沈运朋 Man Yanru;Dong Juan;Liu Jiao;Cheng Ningning;Shen Yunpeng(Shandong Lukang Pharmaceutical Co.,Jining 272100,China)

机构地区：[1]山东鲁抗医药股份有限公司,山东济宁272100

出　　处：《山东化工》2024年第17期186-189,共4页Shandong Chemical Industry

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 C_(18)色谱柱(4.0 mm×125 mm,5μm),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≥0.9999);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。Objective:To establish a HPLC method for the determination of related substances in cefixime tablets.Methods:The analytical column was Welch XB C_(18)(4.0 mm×125 mm,5μm),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≥0.9999).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.

关 键 词：头孢克肟片 有关物质 高效液相色谱法 

分 类 号：O657.7[理学—分析化学]