硫酸沙丁胺醇控释胶囊释放度的HPLC测定

Determination of dissolution of salbutamol controlled-release pellets capsule by HPLC

目的 建立HPLC测定硫酸沙丁胺醇控释小丸胶囊释放度的方法。方法 采用腈基键合硅胶柱 (SpherisorbCN 2 5cm× 4.6mm) ;以水 - 0 0 5mol ml醋酸铵 -异丙醇 (30 ∶6 5 ∶5 )为流动相 ;流速为 2ml min ;检测波长为 2 76nm。结果 线性范围为 0 48～19 2 0 μg ml,r=1 0 0 0 ;回收率为 95 3%～ 99 5 % ,RSD <1 31% (n =6 )。 结论 本方法快捷、简便、准确 。

Objective A HPLC method was established to determine the dissolution of salbutamol capsules. Methods Spherisorb CN(25cm×4 6mm) was used as a statephase. The mobile phase is water-0.05mol/L NH 4Ac-Isopropanol(30∶65∶5)solution adjusted at pH4.5 by acetic acid. The flow rate was 2ml/min and the detective wavelength is 270nm. Results In the concentration range of 0 48～19.20μg/ml,a linearity can be found. The method recovery rate was 95.3～99.5%,RSD<1.31%(n=6). Determination of the salbutamol dissolution sample was achieved with a high precision and a low variation. Conclusion This method is accurate,highly sensitive,simple and quick.