尼可地尔原料药含量测定方法的比较研究

Comparative study on determination method of nicorandil

目的比较尼可地尔原料药含量测定的不同方法,并确立更加简单、快速的含量测定方法。方法采用高效液相色谱法测定尼可地尔原料药的含量,并与日本药局方第16改正版中收载的非水滴定法进行比较。结果采用高效液相色谱法尼可地尔的线性范围为14.32-238.60μg/m L（r=1.0000）,平均回收率为100.2%（RSD=0.5%）。两种方法的测定结果无显著性差异。结论高效液相色谱法简单、快速、准确,可作为尼可地尔原料药的含量测定方法。

Objective To compare different methods for the determination of nicorandil and establish a more simple and faster determination method. Methods The HPLC method was used to determine the content of nicorandil and compared with nonaqueous titration method stated in the Japanese pharmacopoeia sixteenth edition. Results The linear range of nicorandil was 14.32- 238.60μg/m L（r=1.0000）,and the average recovery rate was 100.2%（RSD=0.5%）by HPLC. There was no significant difference between the results of HPLC and nonaqueous titration method. Conclusion The HPLC method was simple, fast and accurate, which could be used to determine the content of nicorandil.