HPLC测定复方氨林巴比妥注射液中的有关物质  

Determination of related substances in Compound aminophenazone and barbital injection by HPLC

作　　者：王非梦 曾令高 尹国平 胡幸 李超 朱晓璐 WANG Feimeng;ZENC Linggao;YIN Guoping;HU Xing;LI Chao;ZHU Xiaolu(NMPA Key Laboratory for Quality Monitoring of Narcotic Drugs and Psychotropic Substances,Chongqing Institute for Food and Drug Control,Chongqing,401121 P.R.China;College of Pharmaceutical Sciences,Southwest University,Chongqing,400715 P.R.China)

机构地区：[1]重庆市食品药品检验检测研究院国家药品监督管理局麻醉精神药品质量监测重点实验室,重庆401121 [2]西南大学药学院,重庆400716

出　　处：《华西药学杂志》2024年第2期190-193,共4页West China Journal of Pharmaceutical Sciences

基　　金：重庆市技术创新与应用发展专项资助项目(CSTB2022TIAD-GPX0071)。

摘　　要：目的采用HPLC测定复方氨林巴比妥注射液中的有关物质。方法采用加校正因子的主成分自身对照法。采用Waters Sunfire-C18色谱柱(250 mm×4.6 mm,5μm),流动相为0.01 mol·L^(-1)乙酸铵缓冲液(pH7.7)-乙腈(85:15),流速1.2 mL·min^(-1),柱温35℃,检测波长228 nm,进样量10μL。结果杂质A、杂质B、安替比林、氨基比林在各自相应浓度范围内与峰面积呈现良好线性关系,定量限分别为0.050、0.093、0.014、0.041 mg·L^(-1);杂质A、B的平均加样回收率为101.5%、103.7%,RSD分别为2.90%、4.40%。结论所用方法简便快速、稳定性好,可用于复方氨林巴比妥注射液中有关物质的测定。OBJECTIVE To detect the related substances in Compound aminophenazone and barbital injection by HPLC.METHODS The test was carried out using principal component self control method with calibration factors.Waters Sunfire Cis column was used.Elute with 0.01 mol·L^(-1)ammonium acetate buffer(pH7.7)-acetonitrile(85:15),flow rate of 1.2 mL.min^(-1),column temperature of 35℃C,detection wavelength of 228 nm,and injection volume of 10μL.RESULTS SImpurityA,impurity B,antipyrine,and aminopyrine showed good linear relationship within their respective concentration ranges,with quantification limits of 0.050,0.093,0.014,and 0.041 mg·L^(-1),respectively.The average recovery rates of impurities A and B were 101.5%and 103.7%,with RSDs of 2.90%and 4.40%.CONCLUSION This method is simple,rapid.It can be used for the quantitative determination of related substances in compound Aminophenazone and barbital injection.

关 键 词：复方氨林巴比妥注射液 有关物质 高效液相色谱法 加校正因子的主成分自身对照法 含量测定 

分 类 号：R917[医药卫生—药物分析学]