超高效液相色谱法测定罗红霉素分散片的溶出度

Determination of dissolution of roxithromycin dispersible tablets by UPLC

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pH值至7.5）-乙腈（50∶50）,流速：0.65mL/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/mL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 UPLC method for determination dissolution of roxithromycin dispersible tablets. Methods Separation was performed on an Agilent XDB-C18 column（50mm×4.6mm, 1.8μm）. Mobile phase was 0.067mol/L diammonium dihydrogen phosphate solution（adjust pH to 7.5 by adding triethylamine） and acetonitrile（50：50）, The flow rate was 0.65mL/min. The detection wavelength was 205nm. The colum temperature was maintained at 35 ℃. Results The method has good specificity; The linear range of the method was 25.2-225.2μg/mL with a correlation coefficient of 0.9999; The recovery was 99.5% with the RSD of 0.93%（n=12）. Conclusion The method was simple, rapid and accurate for the determination of dissolution of roxithromycin dispersible tablets.