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本文建立了测定海力特胶囊含量和体外溶出度的高效液相色谱方法。采用 Aminex HPX-87H(30 0 mm× 7.8mm)柱 ,以 0 .0 0 2 5 mol· L-1H2 SO4 为流动相 ,柱温为 6 5℃ ,流速为 0 .5 m L·min-1,以示差检测器检测 ,外标法峰面积定量。本法测定线性范围为 1μg～ 4 0μg,方法平均回收率为96 .1% ,RSD为 0 .83% (n=5 ) ,体外溶出度测定结果为 96 %～ 99%。本法测定海力特胶囊含量和溶出度 ,具有方法简便、快捷 ,重复性好的特点 ,可作为制剂质量控制方法。
In this paper, a high performance liquid chromatography (HPLC) method was established to determine the content and in vitro dissolution of Hilti Capsule. Amoxicx HPX-87H (300 mm × 7.8 mm) was used as the mobile phase at a flow rate of 0.05 mL · L -1 , To differential detector detection, external standard peak area of quantitative. The linear range of this method was 1μg ~ 40μg. The average recovery was 96.1% with a RSD of 0.83% (n = 5). The in vitro dissolution rate was 96% -99%. This method for the determination of the sea of special capsule content and dissolution, with the method is simple, fast, good repeatability, can be used as the preparation of quality control methods.