高效分子排阻色谱法在测定盐酸头孢替安酯中高分子杂质含量中的应用效果

The application of high efficiency molecular exclusion chromatography in the determination of macromolecular impurities in cefotiam hydrochloride

目的:分析高效分子排阻色谱法在测定盐酸头孢替安酯中高分子杂质含量中的应用效果。方法:采用TSK-GEL G2000SW_(XL)色谱柱(规格:300×7.8 mm,5 μm)对盐酸头孢替安酯中高分子杂质的含量进行色谱分析(以0.03 mol·L^(-1)的磷酸二氢钠溶液为流动相)。色谱仪参数设置:流速为每分钟0.5 mL,检测波长为254 nm,进样量为20 μL。分析结束后,观察样品中高分子杂质含量的检出情况。结果:供试品溶液在0.25~2.5 mg·mL^(-1)浓度范围内与峰面积有良好的线性关系,r^2=0.9997。对照品重复性试验RSD为1.9%,供试品重复性试验RSD为1.4%。结论:文中所建立的盐酸头孢替安酯中高分子杂质测定方法稳定、可重现,可用于对本品进行质量控制。

objective:to analyze the application of high efficiency molecular exclusion chromatography in the determination of polymer impurities in cefotiam hydrochloride.Methods:tsk-gel G2000SWXL column(size:300×7.8mm,5 m)was used for chromatographic analysis of the content of macromolecular impurities in cefotean hydrochloride(0.03mol·l-1 sodium dihydrogen phosphate solution was used as mobile phase).Chromatograph parameters were set:the flow rate was 0.5 mL per minute,the detection wavelength was 254 nm,and the injection volume was 20 liters.After the analysis,the detection of polymer impurities in the samples was observed.Results:the sample solution had a good linear relationship with the peak area in the concentration range of 0.25~2.5 mg·ml-1,r2=0.9997.The RSD of the control substance was 1.9%,and that of the supplied substance was 1.4%.Conclusion:the method for the determination of macromolecular impurities in cefotetranium hydrochloride is stable and reproducible,and can be used for q uality control of this product.