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目的建立超高效液相色谱法(UPLC)测定阿奇霉素分散片的含量。方法采用Agilent XDB-C_(18)(50mm×4.6mm,1.8μm)色谱柱,流动相为磷酸盐缓冲液(取0.05mol/L磷酸氢二钾溶液,用20%磷酸溶液调p H至8.2)-乙腈(50:50),流速为1.0m L/min,检测波长为210nm,柱温35℃。结果本法具有良好的专属性;在0.504~1.507mg/m L范围内,浓度与峰面积呈良好的线性关系(R~2=0.9998);平均回收率为99.78%,RSD为0.81%(n=9)。结论所用方法准确、可靠、耐用性强,可用于阿奇霉素分散片的含量测定。
Objective To establish a method for the determination of azithromycin dispersible tablets by ultra performance liquid chromatography (UPLC). Methods Agilent XDB-C 18 column (50mm × 4.6mm, 1.8μm) was used. The mobile phase consisted of phosphate buffer (0.05mol / L potassium phosphate dibasic solution and pH = 8.2 with 20% phosphoric acid solution ) -acetonitrile (50:50) at a flow rate of 1.0 m L / min with a detection wavelength of 210 nm and a column temperature of 35 ° C. The results showed that this method had good specificity. The linear range was 0.504 ~ 1.507 mg / m L (R ~ 2 = 0.9998). The average recovery was 99.78% and the RSD was 0.81% (n = 9). Conclusion The method used is accurate, reliable and robust. It can be used for the determination of azithromycin dispersible tablets.