阿奇霉素有关物质测定方法的优化分析

目的采用色谱分析法对阿奇霉素相关物质的进行测定,探讨测定方法的优化。方法采用相色谱系统仪器、岛津Class-10Avp系统完成测定,色谱柱为SHISEIDO CAPCELL PAK C18 MG,规格为5μm,250mm×4.6mm。流动相为磷盐酸缓冲液,以0.05mol/L的磷酸氢二钾溶液,以浓度为20%的磷酸调节,直至pH值为8.2;色谱纯试剂乙腈为45∶55;色谱柱温度为30℃;流速为每分钟10mL;检测波长为210nm;进样量为50μL。结果溶液浓度为10~1000μg/mL的范围内的线性关系,结果表明线性关系良好。方法的最低检出限为100ng,r=0.9999。结论本次研究所采用的测定方法能够有效测定阿奇霉素中的相关物质,具有良好的分离性与浓度峰面线性关系。

The Material of the Determination Method of Azithromycin Optimization Analysis

Objective The chromatographic analysis method of azithromycin related material, this paper discusses the determination method of optimization. Methods Use phase chromatographic system instrument, island Class tianjin-10 Avp system was completed, chromatographic column for SHISEIDO CAPCELL PAK C18 MG, specifications for 5μm, 250mm×4.6mm. For mobile phase phosphorus hydrochloric acid buffer to 0.05mol/L of two hydrogen potassium phosphate solution, the concentration of 20% to the phosphoric acid adjustment, until the pH value of 8.2; chromatographic pure reagent acetonitrile is 45 ： 55; chromatographic column for 30 degrees celsius temperature; for every minute and 10mL flow; detected wavelength for 210nm; Sample quantity of 50μL. Results The solution concentration of 10-1000μg/mL within the scope of the linear relationship, and the results show that good linear relationship. Methods the lowest detection limit for 100ng, r=0.9999. Conclusion This research institute of the determination method can effectively determination of azithromycin related material, have good separation sex and concentration peak linear relationship between the surface.