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目的建立超高效液相色谱法(UPLC)测定罗红霉素分散片的溶出度。方法采用Agilent XDB-C18(50mm×4.6mm,1.8μm)色谱柱,流动相为0.067mol/L磷酸二氢铵溶液(用三乙胺调p H值至7.5)-乙腈(50∶50),流速:0.65m L/min,检测波长:205nm,柱温:35℃。结果本法具有良好的专属性;在25.2~225.2μg/m L范围内,浓度与峰面积呈良好的线性关系(R2=0.9999);平均回收率为99.5%,RSD为0.93%(n=12)。结论所用方法快速、灵敏,结果准确可靠,可用于罗红霉素分散片的溶出度测定。
Objective To establish a method for the determination of roxithromycin dispersible tablets by ultra performance liquid chromatography (UPLC). Methods The Agilent XDB-C18 (50mm × 4.6mm, 1.8μm) column was used. The mobile phase consisted of 0.067mol / L ammonium dihydrogen phosphate solution (adjusted to pH value of 7.5 with triethylamine) -acetonitrile (50:50) Flow rate: 0.65 m L / min, detection wavelength: 205 nm, column temperature: 35 ° C. The results showed that the method was well-defined. The linear range was 25.2 ~ 225.2μg / m L (R2 = 0.9999). The average recovery was 99.5% and the RSD was 0.93% (n = 12 ). Conclusion The method is rapid, sensitive and the results are accurate and reliable. It can be used for the determination of dissolution of roxithromycin dispersible tablets.