HPLC-电化学法测定胞磷胆碱钠注射液中游离胆碱含量

目的建立胞磷胆碱钠注射液中游离胆碱含量测定方法。方法采用高效液相色谱电化学检测法,专用色谱柱（ESA ACH-3,250 mm×3 mm ID）和固相胆碱氧化酶反应器（ESA ACH-SPR,3 cm）,M5040分析电极和5300型电化学检测器,柱温：35℃,流速：0.35 ml.min-1。结果游离胆碱在0.12～2.89μg.ml-1范围内呈良好线性关系,r=0.9999,平均回收率为100.0%,RSD为2.7%（n=6）。结论该方法简便可行,重复性好,可用于胞磷胆碱钠注射剂中游离胆碱含量测定。

Determination of Free Choline in Citicoline Sodium Injection by HPLC with Electrochemical Detection Combined with a Post-Column Immobilized Enzyme Reactor

Objective To determine free choline in citicoline sodium injection. Methods HPLC was used together with electrochemical detection combined with a post-column immobilized enzyme reactor （IMER）. This assay was based on the separation of choline on a polymer gel column （ESA ACH-3,250 mmx 3 mm ID i followed by the passage of the effluent through an IMER（ESA ACH-SPR,3 cm） ,on which the separated choline reacted respectively to give each stoichiometric yield of hydrogen peroxide, which was detected electrochemically at an electrode （ESA M5040, E1 ： ＋300 mV）. The flow rate was 0.35 ml .rain-1 ,and the column temperature was 35 ℃. Results The linear range of free choline was 0. 12-2.89 p,g .m l-l（ r = 0. 9999）, The average recovery was 100.0% and RSD was 1.6%. Conclusion This method can be used for quality control of free choline in citicoline sodium injection.