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HPLC法测定氢溴酸西酞普兰咀嚼片的溶出度
引用本文:曹天海.HPLC法测定氢溴酸西酞普兰咀嚼片的溶出度[J].云南民族大学学报(自然科学版),2016(4):325-328,335.
作者姓名:曹天海
作者单位:昆明积大制药股份有限公司国际GMP认证部
摘    要: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C_(18)色谱柱,0.1 mol/L V(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p H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.

关 键 词:氢溴酸西酞普兰咀嚼片  高效液相色谱  溶出度  测定

Determination of the dissolution of citalopram hydrobromide chewable tablets by HPLC
CAO Tian-hai.Determination of the dissolution of citalopram hydrobromide chewable tablets by HPLC[J].Journal of Yunnan Nationalities University:Natural Sciences Edition,2016(4):325-328,335.
Authors:CAO Tian-hai
Institution:CAO Tian-hai;International GMP Certification Department,Kunming Jida Pharmaceutical Co.,Ltd.;
Abstract:An HPLC method was established for the determination of the dissolution of citalopram hydrobromide chewable tablets. A C_(18) column was used with the mobile phase of acetonitrile- 0. 1mol / L ammonium acetate solution- 0. 01 mol / L sodium 1- heptanesulfonate( 4 ∶ 6 ∶ 1)( p H adjusted to 6. 0 by glacial acetic acid) at the wavelength of 238 nm. The results showed that the calibration curve of citalopram hydrobromide was linear in the concentration range 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 recovery was 102. 4%. The method was simple,convenient,rapid and accurate. It could be used as a method of quality control.
Keywords:citalopram hydrobromide chewable tablets  HPLC  dissolution  determination
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