关键词: font-size:medium, ">吡拉西坦氯化钠注射液；有关物质；高效液相色谱法；稳定性；影响因素

Abstract: Objective： To establish a method for the determination of related substances in Piracetam and sodium chloride injection， and to investigate the influence of related factors. Methods： High Performance Liquid Chromatography(HPLC) was performed on an octadecylsilane bonded silica gel column（DIKMA Platisil ODS 5 μm 250×4.6 mm）， The mobile phase was Dipotassium phosphate solution(pH to 6.0 with 50% phosphoric acid) /acetonitrile in a gradient elution. The flow rate was 1.0 mL·min-1. Column temperature was 35 ℃. The detection wavelength was 210 nm. Injection volume was 10 μL. Results： The linear ranges of Piracetam and impurities A，B，C，D were 0.255 2-1.020 8， 0.245 8-0.983 2， 0.252 7-1.010 8， 0.258 9-1.035 6， 0.245 1-0.980 4 μg·mL-1. The correction factors of the 4 impurities were 1.3， 1.3， 1.5 and 0.8. The detection limits were 3.527， 10.304， 30.554， 1.981 ng·mL-1 respectively. The quantification limits were 8.817， 25.760， 76.384， 4.952 ng·mL-1 respectively. The recoveries were 90.18%-105.20%(RSD=1.5%-3.3%， n=9). There was a tendency of degradation during the storage of Piracetam sodium chloride injection. Impurity D is the main degradation product. The higher the temperature is， the faster the degradation rate is. Conclusion： The established method can accurately determine the related substances in Piracetam sodium chloride injection with good specificity and high sensitivity. The main factors affecting the related substances in Piracetam sodium chloride injection are temperature and storage time， enterprises should pay attention to the selection of sterilization conditions， and control and monitor the storage temperature in the whole circulation to ensure product quality and people′s safety.

Key words: font-size:medium, ">Piracetam and Sodium Chloride Injection； Related substances；High performance liquid chromatography(HPLC)；Stability；Influencing factors