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《Chinese New Drugs Journal》 2003-12
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HPLC measurement of related substances and citicoline content in citicoline sodium and NaCl injection

ZHENG Zhao-hua,CHEN Yu-ying,DU Ying-xiang (Department of Analytical Chemistry, China Pharmaceutical University, Nanjing 210009, China)  
Objective:To establish a method for measurement of related substances and citicoline content in citicoline sodium and NaCl injection. Method:Chromatographic conditions were as follows:a C18 column (200mm×4. 6mm,5μm) ,a mobile phase consisting of 0.01mol·L-1 KH2PO4 solution (pH 4.0) ,and a UV detector at 280nm. Results:The related substanese can be completely separated from citicoline. For citicoline sodium,a linear range of 26 - 157μg·mL-1 ,an average recovery of 102.5% , and a RSD of 0.87% were obtained. Conclusion:Related substances in citicoline sodium and NaCl injection can be accurately and selectively measured by the HPLC method and the content of citicoline in the injection can also be determined by this method.
【Key Words】: citicoline sodium HPLC related substances determination injection
【CateGory Index】: R927.2
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