十一酸睾酮胶囊体外溶出度的测定

Dissolution detection of testosterone undecanoate capsule in vitro

目的 HPLC法测定十一酸睾酮胶囊的体外溶出。方法采用《中国药典》2015年版溶出度测定第二法,以p H6.8的磷酸缓冲液(含0.25%十二烷基硫酸钠)900 ml为溶出介质,转速75 r/min,溶出时间为120 min。使用HPLC法对溶出样品检测,采用phenomenex~@C_(18)色谱柱(4.6 mm×250 mm,5μm);流动相:异丙醇-乙腈-水(45∶45∶10,V/V/V);流速:1.0 ml/min;检测波长:240 nm;柱温:40℃;进样量:20μl。结果本法平均回收率为100.55%(n=9);在1~50μg/ml范围内线性关系良好(R^2=0.9999,n=3)。结论方法简便、灵敏、准确、专属性强;可用于十一酸睾酮胶囊溶出度的检测。

Objective To determin the dissolution of testosterone undecanoate capsule in vitro with an established HPLC method. Methods The dissolution was determined by the second method described in China（Ch P）2015,Pharmacopoeia. Totally900 ml of 0.25% sodium lauryl sulfate solution with p H 6.8 phosphate buffer were used as dissolution media,and the rotation speed was 75 r/min. The dissolution time was 120 min and the dissolution was determined by HPLC. The HPLC column was phenomenex~@C_（18）column（250 mm×4.6 mm,5μm）. The mobile phase was 2-propanol-acetonitrile-water（45∶45∶10,V/V/V）with a flow rate of 1.0 ml/min and the detection wavelength of 240 nm. The column temperature was 40℃ and the injection volume was 20 μl. Results The average recovery of the method was about 100.55%（n=9）. The calibration curves showed good linearity（r^2=0.9999,n=7）within ranges of 1-50 μg/ml. Conclusion The method is convenient and sensitive in the dissolution determination of testosterone undecanoate capsule.