阿米三嗪二甲烷磺酸盐的高效液相色谱快速分析

Determination of Almitrine Bismesylate by High Performance Liquid Chromatography

本文对新药阿米三嗪二甲烷磺酸盐及其相关杂质的紫外吸收光谱和色谱行为进行了详细考查。最佳色谱分离条件为：色谱分离柱为CLC－CN（150×6．0mmⅠ．D．），流动相为甲醇-水（8／2，V／V），流速为1．0mL／min，检测波长为225nm。在最佳色谱条件下，测定阿米三嗪二甲烷磺酸盐的线性范围是0．01～100mg／L。回收率为97.8％～101．5％，相对标准偏差小于3．5％。对实际样品测定，结果满意。

In this paper ultra violet spectrophotometric and chromatographic behaviors of almitrine bismesylate and its related impurities were studied, optimal chromatographic conditions were established and a rapid analytical method for almitrine bismesylate by HPLC was developed. The linear range was 0. 01 ~ 100 mg/L, recovery was 97. 8%~ 101. 5% andR. S. D. was less than 3. 5 %. Some samples were analyzed with satisfactory results.