罗红霉素电子药膜含量测定方法的研究

目的 :建立测定罗红霉素电子药膜中主药含量的方法。方法 :采用高效液相色谱法 ,色谱柱为YWG C18柱 ,流动相为乙腈—甲醇— 0 .5 %乙酸铵 (10 0 80 6 0 ) ,检测波长为 2 35nm。结果 :精密度及稳定性均良好 ,在 0 .3～ 1.7mg·ml- 1范围内 ,峰面积与浓度 (mg·ml- 1)呈良好的线性关系 ,r =0 .9998,平均回收率为 99.2 3% ,RSD为 0 .84 %。n =5。结论 :本方法简便、专属、重现性好 ,可用于罗红霉素电子药膜剂的含量测定。

Studies on assay of roxithromycin in electron medicinal membrane of roxithromycin

OBJECTIVE To develop a method for assay of roxithromycin in electron medicinal membrane of roxithromycin. METHODS To use a HPLC method by YWG C₁₈ column. The mobile phase was a mixture of acetonitrile-methano-l0.5% ammonium acetate(100:80:60),with the detection wavelength at 235 nm.RESULTS Precision and stability were fine. The linear correlation was observed from the concentrations of 0.3 to 1.7mg·ml^-1(r=0.9998).The average recovery was 99.23%.Resolution bettween roxithromycin and other peaks met the requirements.CONCLUSION The method is convenient, selective and reproducible.