HPLC法测定胞磷胆碱钠氯化钠注射液中胞磷胆碱钠的含量

High-Performance Liquid Chromatography the Content Measure of Sodium Citicoline in Sodium Citicoline NaCI Parenteral Solution

目的:建立胞磷胆碱钠氯化钠注射液中胞磷胆碱钠含量测定方法。用于生产及市场监控。方法:选用 C_(15)(250×46mm)5μm 色谱柱,0.02mol/L 磷酸二氢钾水溶液为流动相,检测波长275nm,采用高效液相色谱法测定胞磷胆碱钠的含量;结果:胞磷胆碱钠在28.4～568.0μg/mL 浓度范围内呈良好线性,其回收率为100.07%(RSD=0.399 n=9):结论:上述方法简便、快捷,结果准确,可用于胞磷胆碱钠氯化钠注射液中胞磷胆碱钠含量测定和质量控制。

Objective:Set up the method of the content measurement for Sodium Citicoline in Sodium Citicoline NaCl Parenteral Solution for the using of supervision in the production and marketing.Measure:Take C_(18) (250×4.6mm) 5μm chromatographic column,0.02mol/L aqueous solution of monopotassium phosphate as mobile phase,measuring wave-length 275nm,the high performance liquid chromatography is adopted to measure the content of Sodium Citicoline.Re- sult:In the concentration of 28.4～568.0/μg/mL the Sodium Citicoline presents nicer linearity,the rate of callback is 100.07%(RSD=0.399 n=9);Conclusion:This method is convenient,shortcut and has exact outcome,can be used for the content measure of the Sodium Citicoline in Sodium Citicoline NaCl Parenteral Solution and quality control