高效液相色谱法测定去氧孕烯炔雌醇片的溶出度  

Dissolution detection of desogestrel and ethinylestradiol tablets by HPLC

作　　者：马春辉[1] 孙建绪[1] 郭飞[1] 李迎[1] 张慧[1] 郑爱萍[1] 

机构地区：[1]军事医学科学院毒物药物研究所药物制剂室,抗毒药物与毒理学国家重点实验室,北京100850

出　　处：《国际药学研究杂志》2016年第6期1164-1168,共5页Journal of International Pharmaceutical Research

摘　　要：目的 建立去氧孕烯炔雌醇片的溶出度测定方法。方法 采用《中国药典》2015年版四部溶出度与释放度测定法第二法（桨法）,以500 ml 0.05%的十二烷基硫酸钠水溶液为溶出介质,转速50 r/min,溶出时间30 min,HPLC条件采用Agilent SB C18柱（150 mm×4.6 mm,5μm）;流动相：乙腈为流动相A,乙腈-水（50∶50,V/V）为流动相B,流速为1 ml/min,梯度洗脱;检测波长：210 nm;柱温：40℃;进样量：100μl。结果 该法回收率去氧孕烯为99.68%;炔雌醇为99.40%;样品溶液室温下12 h内稳定;去氧孕烯在（0.06~0.36）μg/ml范围内线性关系良好（r=0.9999）,炔雌醇在（0.012~0.072）μg/ml范围内线性关系良好（r=0.9999）。结论 该法简便、准确、灵敏度较高、专属性好,可用于去氧孕烯炔雌醇片溶出度的检测。Objective To develop a HPLC method for determining the dissolution of desogestrel and ethinylestradiol tablets.Methods The dissolution was determined by the second method described in Chinese Pharmacopoeia（Ch P）2015. In total 500 ml of0.05% sodium lauryl sulfate solution was used as dissolution media,and the rotation speed was 50 r/min. The dissolution time was 30 min and the dissolution was determined by HPLC. The HPLC column was Agilent SB C18column（150 mm×4.6 mm,5 μm）. The mobile phase：acetonitrile as mobile phase A,acetonitrile-water（50∶50,V/V）as mobile phase B with gradient elution. The flow rate was 1 ml/min.The detection wavelength of desogestrel and ethinylestradiol was 210 nm. The column temperature was 40℃ and the injection volume was 100 μl. Results The average recoveries were 99.68% for desogestrel and 99.40% for ethinylestrsdiol,and the stability of working solutions was acceptable in 12 h. The calibration curves were linear within the range of（0.06-0.36）μg/ml（r=0.9999）for desogestrel,（0.012-0.072）μg/ml（r=0.9999）for ethinylestradiol,respectively. Conclusion The method is convenient and precise in the dissolution determination of desogestrel and ethinylestradiol tablets.

关 键 词：高效液相色谱法 去氧孕烯炔雌醇片 溶出度 

分 类 号：R927[医药卫生—药学] O657.72[理学—分析化学]