反相高效液相色谱法测定格列苯脲缓释微丸胶囊主药含量

摘要

Objective To establish a method for the determination of the glibenclamide content in Glibenclamide Sustained Release Pellets Capsules.Methods HPLC was performed on the Waters Xterra RP18 column(250 mm×4.6 mm,5 μm) with methanol-0.05 mol/L sodium dihydrogen phosphate (30∶ 70) as the mobile phase and the flow rate of 1 mL/min.The detection wavelength was at 300 nm.The column temperature was 35 ℃ and the sample size was 20 μL.Results The linear range of glibenclamide was 0.5-3.0 μg (r =0.999 9),the average recovery rate was 99.95％,RSD =0.80％ (n =6).Conclusion This method is simple,accurate,highly specific and can be used for the quality control of this preparation.%目的 建立测定格列苯脲缓释微丸胶囊中格列苯脲含量的高效液相色谱法.方法 以Waters Xterra RP18柱(250 mm×4.6 mm,5 μm)为色谱柱,流动相为甲醇-0.05 mol/L磷酸二氢钠水溶液(30∶70),检测波长为300 nm,流速为1 mL/min,柱温为35℃,进样量为20 μL.结果 格列苯脲进样量在0.5～3.0μg范围内与峰面积呈良好线性关系,平均回收率为99.95％,RSD =0.80％ (n =6).结论 该方法简便、准确、专属性强,可用于该制剂的含量测定.