离子色谱法测定氯化琥珀胆碱原料及注射液中的氯化胆碱和氯化琥珀酰单胆碱

Determination of Choline Chloride and Succinylmono Choline in Succinycholine Chloride API and Its Injection by Ion Chromatography

关键词:  氯化琥珀胆碱  氯化胆碱  氯化琥珀酰单胆碱  离子色谱法

Key words:  succinycholine chloride  choline chloride  succinylmono choline  ion chromatography

摘要:

目的 采用离子色谱法测定氯化琥珀胆碱原料及注射液中的氯化胆碱和氯化琥珀酰单胆碱。方法 采用Dionex RFICTM Ionpac CS17色谱柱（4 mm×250 mm），以甲烷磺酸溶液为流动相进行梯度洗脱，流速为1.0 mL·min^-1，采用抑制电导检测器进行测定。结果 氯化胆碱、氯化琥珀酰单胆碱浓度分别在18.0~562.8 μg·mL^-1（r=0.999 9）和14.4~449.8 μg·mL^-1（r=0.999 9）内线性关系良好，定量限均为0.01 μg·mL^-1。原料中氯化胆碱、氯化琥珀酰单胆碱回收率分别为103.4%~105.7%和102.4%~107.1%；注射液中氯化胆碱、氯化琥珀酰单胆碱回收率分别为95.6%~100.2%和94.4%~103.5%。结论 该方法专属性强、准确、简便、快速，适用于氯化琥珀胆碱原料及制剂中的有关物质测定。

Abstract:

OBJECTIVE To establish an ion chromatography method for determination of choline chloride and succinylmono choline in succinycholine chloride API and its injection. METHODS The Dionex RFICTM Ionpac CS17 column(4 mm×250 mm) was adopted. The mobile phase consisted of methanesulfonic acid with gradient elution. The flow rate was 1.0 mL·min^-1. The detection was performed by a conductivity detection mode. RESULTS The linear correlation coefficient of choline chloride and succinylmono choline were both 0.999 9 in the range of 18.0-562.8 μg·mL^-1 and 14.4-449.8 μg·mL^-1, respectively. The limit of determination of choline chloride and succinylmono choline was 0.01 μg·mL^-1. The recoveries of choline chloride and succinylmono choline in API were 103.4%-105.7% and 102.4%-107.1%, respectively. The recoveries of choline chloride and succinylmono choline in its injection were 95.6%-100.2% and 94.4%-103.5%, respectively. CONCLUSION The method is specific, accurate, simple and quick for determination of choline chloride and succinylmono choline in succinycholine chloride API and its injection.