HPLC法测定氢溴酸西酞普兰咀嚼片的溶出度

Determination of the dissolution of citalopram hydrobromide chewable tablets by HPLC

建立高效液相色谱法测定氢溴酸西酞普兰咀嚼片溶出度的方法.采用C18色谱柱,0.1 mol/LV（乙腈）∶0.01 mol/L V（醋酸铵）∶V（庚烷磺酸钠）=4∶6∶1（以冰醋酸调节pH值至6.0）为流动相,检测波长为238 nm.结果表明,氢溴酸西酞普兰在0.032 2～0.112 8 mg/ml浓度范围内线性关系良好,定量限和检测限为1.5 ng及0.5 ng,方法回收率为102.4％.该方法简便,快速,准确,可用于其质量控制.

An HPLC method was established for the determination of the dissolution of citalopram hydrobromidechewable tablets. A C18 column was used with the mobile phase of acetonitrile - 0 . 1m ol/L ammonium acetate solution- 0 . 01 mol/L sodium 1 - heptanesulfonate（4：6： 1 ） （pH adjusted to 6. 0 by glacial acetic acid） at the wavelengthof238nm. The results showed that the calibration curve of citalopram hydrobromide was linear in the concentrationrange of 0. 032 2 mg/ml - 0. 1 128 mg/ml. The LOQ and LOD were 1. 5 ng and 0. 5 ng. The average recoverywas 102. 4 % . The method was simple, convenient, rapid and accurate. It could be used as a method of qualitycontrol.