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关键词：测定 色谱 液相 胶囊 色谱法
吕志华 赵 峡
（青岛海洋大学海洋药物与食品研究所, 青岛, 266003）
摘 要 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(300mm×7.8mm)柱，以0.002 5mol·L-1H2SO4为流动相，柱温为65℃，流速为0.5mL·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～40μg，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。
关键词 海力特胶囊；高效液相色谱法；溶出度
中图法分类号 R282.77 文章编号1001-1862(2002)02-241-04
HPLC Determination of the Content and DissolutionRate in Vitro of Hailite Capsules
Lü Zhihua Zhao Xia
（Marine Drug and Food Institute ,Ocean University of Qingdao, Qingdao 266003, China）Abstract To develop a reliable method for the determination of the contents and dissolution rate in vitro of Hailite capsules by HPLC, an Aminex HPX-87H(300mm×7.8mm)column was used. The mobile phase was 0.0025mol·L-1H2SO4at a flow rate of 0.5mL·min-1, the column tempereture was 65℃, and an RI detector was used. The content of the capsules was quantitated by peak area with external standard. The standard curve was linear in the range of 1μg～40μg. The average recovery was 96.1% with an RSD of 0.83%(n=5). The dissolution rate in vitro was 96%～99%. The new method is very suitable for the determination of capules as it is simple, rapid, accurate and of good reproducibility.
Key words Hailite capule; HPLC; dissolution rate in vitro
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