阿奇霉素有关物质测定方法的优化分析

The Material of the Determination Method of Azithromycin Optimization Analysis

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.

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.