HPLC法测定黄体酮纳米晶体胶囊的溶出度

发布时间：2018-01-16 18:13

  本文关键词：HPLC法测定黄体酮纳米晶体胶囊的溶出度　出处：《国际药学研究杂志》2015年03期 　论文类型：期刊论文

  更多相关文章： 黄体酮纳米晶体胶囊 高效液相色谱法 溶出度

【摘要】：目的建立黄体酮纳米晶体胶囊的溶出度考察方法。方法采用《中国药典》2010年版溶出度测定第一法,以900 ml浓度为0.25%十二烷基硫酸钠溶液为溶出介质,转速75 r/min,溶出时间为45 min。使用HPLC法对溶出样品检测,采用Agilent TC C18色谱柱(150 mm×4.6 mm,5μm);流动相:甲醇-乙腈-水(35∶40∶25,V/V/V);流速:1.0 ml/min;检测波长:241 nm;柱温:25℃;进样量:20μl。结果本方法平均回收率为100.02%(n=15);溶液在24 h保持稳定(RSD=0.92%,n=8);在2.78~66.7μg/ml范围内线性关系良好(r=1,n=6)。结论方法简便、灵敏、准确、专属性强,可用于黄体酮纳米晶体胶囊溶出度的检测。
[Abstract]:Objective to establish a method for the determination of dissolution of progesterone nanocrystalline capsules. Methods the first method was used to determine the dissolution of progesterone nanocrystalline capsules in the 2010 edition of Chinese Pharmacopoeia. 0.25% ml 0.25% 12 sodium alkyl sulfate solution was used as the dissolution medium, the rotation speed was 75 r / min and the dissolution time was 45 min. The dissolution samples were detected by HPLC method. The chromatographic column of Agilent TC C18 was 150mm 脳 4.6mm ~ 5 渭 m ~ (-1); Mobile phase: methanol-acetonitrile-water 35: 40: 25 V / V / V / V; Flow rate: 1.0 ml / min; Detection wavelength: 241nm; Column temperature: 25 鈩，

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