离子色谱法测定酚磺乙胺注射液的含量

Determination of Etamsylate in Etamsylate Injection by Ion Chromatography

目的:建立测定酚磺乙胺注射液中酚磺乙胺含量的方法。方法:采用离子色谱法,色谱柱为CS17A(4mm×250 mm),保护柱为CG17A(4 mm×50 mm);检测器采用带DIONEX CSRS~300 4-mm抑制器的电导检测器;流动相为5 mmol·L^(-1)甲烷磺酸溶液,流量为1 mL·min^(-1);柱温30℃。结果:酚磺乙胺在0.052 25~1.045 mg·mL^(-1)范围内,色谱峰面积与其浓度呈良好线性关系(Y=0.023X+0.585,r=0.999 9),回收率为101.6%,RSD为0.82%。结论:本方法简便、快速,可准确地对酚磺乙胺注射液中酚磺乙胺含量进行测定。

Objective： To establish a determination method of etamsylate in Etamsylate Injection by ion chromatogra- phy. Methods： The assay was performed on CS17A column （4 mm× 250 mm） and CG17A guard column （4 mm × 50 mm） by the conductivity detector with DIONEX CSRS ~ 300 4-mm suppressor. The mobile phase was 5 mmol ·L^-1 methane sulfonic acid solution, the flow rate was 1 mL · min^-1, and the column temperature was 30℃. Results： There was a good linearity between peak area and concentration （Y = 0. 023X ＋ 0. 585, r =0. 999 9） in the range of 0. 052 25 - 1. 045 mg · mL^-1 with the average recovery as 101.6% and RSD as 0. 82%. Conclusion： The simple and rapid method can determine the content of etamslate in Etamslate Injection accurately.