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为建立一种实用的反向高效液相色谱法测定罗红霉素胶囊含量的方法,以安捷仑ZORBAX EclipseXDB-C18柱为色谱柱、乙腈-0.02mol/L醋酸铵缓冲液(pH=6.5,体积比65∶35)为流动相,选择210nm为检测波长。结果,罗红霉素的浓度在1.600~102.4mg/L范围内与峰面积呈良好的线性关系,r=0.99977,平均回收率为98.58%,测定结果的相对标准偏差为1.33%。该方法操作简便、快速、实用,测定结果重现性好,可用于该药质量控制。
In order to establish a practical RP-HPLC method for the determination of roxithromycin capsules, an Agilent ZORBAX EclipseXDB-C18 column with acetonitrile-0.02mol / L ammonium acetate buffer (pH = 6.5 , The volume ratio of 65:35) as the mobile phase, select the detection wavelength of 210nm. The results showed that the concentration of roxithromycin had a good linear relationship with the peak area in the range of 1.600 ~ 102.4mg / L, r = 0.99977, the average recovery was 98.58%, and the relative standard deviation was 1.33%. The method is simple, rapid, practical and reproducible. The method can be used for the quality control of the medicine.