高效液相色谱法测定24h型硝苯地平缓释片释放度

Determination of release rate of 24h nifedipine sustained-release tablets by HPLC

目的 建立高效液相色谱法测定 2 4h型硝苯地平缓释片的释放度。方法 采用Shim PackC 18柱 (15 0× 4.6mm ,5 μ) ,甲醇 水 (70∶3 0 )为流动相 ,流速 0 .8mL/min ,检测波长为 2 3 7nm ,外标法测定硝苯地平缓释片溶出液中的硝苯地平浓度 ,计算相应时间内的累积释放百分率。结果 在 1.0 48～ 2 0 .960 μg/mL范围内 ,浓度与峰面积呈良好线性系 (r =0 .9992 ) ,平均加样回收率为 99.6% ,RSD为 1.6%。三批样品 2、4、8及 12h平均累积释放度分别为 (8.0± 1.1) % ,(17.7± 2 .1) % ,(3 3 .7±1.6) %和 (3 9.1± 1.0 ) % ,n =18。结论 本法灵敏、准确 。

OBJECTIVE To establish an HPLC method for the determination of release rate of 24h nifedipine sustained release tablets. METHOD The HPLC method was developed under the following conditions: Shim Pack column, C 18(150×4.6mm,5μ),the mobile phase was methanol water(70:30) and the flow rate was 0.8mL/min, the UV detector was set at 237nm. The nifedipine concentration was determined in dissolution medium by external standard method and the accumulated release rate percentage was calculated.RESULTS The calibration curve was linear in the range from 1.048 to 20.960μg/mL(r=0.9992) and the average recovery was 99.6%(RSD=1.6%). The accumulated release rate of 2,4,8 and 12h were (8.0± 1.1 )%,(17.7±2.1)%,(33.7±1.6)% and (39.1±1.0)% respectively.CONCLUSION The method is sensitive, accurate and suitable for determination the release rate of the sustained release tablets.