单唾液酸四己糖神经节苷脂钠注射液含量测定方法研究

Determination of monosialotetrahexosylganglioside sodium (GM_1) in GM_1 injection

目的:建立单唾液酸四已糖神经节苷脂钠注射液含量测定方法。方法:采用反相高效液相色谱法,色谱柱为大连依利特uBondapak C_(18)柱。流动相为乙腈-0.03％三乙胺(80:20,用磷酸调pH至7.5),检测波长205nm。结果:注射液分析测定无干扰,单唾液酸四已糖神经节苷脂钠浓度在0.05～5mg·mL^(-1)内峰面积与浓度呈良好的线性关系,加样回收率为98.6％～100.9％,RSD≤1.7％。结论:该法专属性强,操作方便,结果准确,重现性好。

Objective:To establish a method for determination of monosialotetrahexoseylgang-lioside sodium (GM1) in GM1 injection. Methods: A RP-HPLC method was selected,the active ingredient was separated with a uBondapak C18 column and detected with a UV detector at 205nm. The mobile phase was composed of acetnitrile-0.03% TEA (80:20) and adjusted to pH 7.5 with H3PO4. Results: A liner range of 0. 05 - 5mg ·mL-1 and a recovery rang of 98. 6% - 100. 9% with a RSD of < 1.7 % were obtained. Conclusion: A simple, accurate, reproducible and selective HPLC method for determination of monosialotetrahexosylganglioside sodium in GM1 injection is established.