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。
Objective To establishe an HPL C method to determine the dissolution of progesterone nanocrystal capsule. Methods The dissolution was determined by the first method described in Chinese pharmacopoeia （ChP） 2010. Totally 900 ml of 0.25% sodium lauryl sulfate solution were used as dissolution media, and the rotation speed was 75 r/min. The dissolution time was 45 min and the dissolution was determined by HPLC. The HPLC column was Agilent TC C18 column （150 mm×4.6 mm,5μm）. The mobile phase was methanol-acetonitrile-water （35∶40∶25,V/V/V）, with a flow rate of 1.0 ml/min and the detection wavelength of 241 nm. The column temperature was 25℃and the injection volume was 20 μl. Results The average recovery of the method was about 100.02%（n=15 ）, and the stability of working solutions was acceptable in 24 h （RSD=0.92%,n=8）. The calibration curves showed good linearity （r=1,n=6） within ranges of 2.78-66.7 μg/ml. Conclusion The method is convenient and sensitive in the dissolution determination of progesterone nanocrystal capsule.
出处
《国际药学研究杂志》
CAS
CSCD
北大核心
2015年第3期404-408,412,共6页
Journal of International Pharmaceutical Research
基金
国家"重大新药创制"科技重大专项资助项目(2012ZX09301003-001-009
2013ZX09J13103-01B
2014ZX09507001003
2014ZX09J14103-01A)
