中国药物评价2024，Vol.41Issue(3)：192-197,6.
吡拉西坦氯化钠注射液有关物质的测定及影响因素考察
Determination of Related Substances in Piracetam and Sodium Chloride Injection and Investigation of Influencing Factors
摘要
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 octa-decylsilane bonded silica gel column(DIKM A 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 correc-tion 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 estab-lished method can accurately determine the related substances in Piracetam sodium chloride injection with good specificity and high sensi-tivity.The main factors affecting the related substances in Piracetam sodium chloride injection are temperature and storage time,enterpri-ses 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.关键词
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Key words
Piracetam and Sodium Chloride Injection/Related substances/High performance liquid chromatography(HPLC)/Stabili-ty/Influencing factors分类
医药卫生引用本文复制引用
张迪,张丽,李尚颖,徐万魁..吡拉西坦氯化钠注射液有关物质的测定及影响因素考察[J].中国药物评价,2024,41(3):192-197,6.基金项目
辽宁省科学技术计划基金项目(No.2020-MS-074) （No.2020-MS-074）
