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
王非梦 1曾令高 2尹国平 3胡幸 2李超 2朱晓璐2
作者信息
- 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;西南大学药学院,重庆 400716
- 2. 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
- 3. 西南大学药学院,重庆 400716
- 折叠
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,5 μm),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10 μL.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.
Abstract
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 C18 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 ℃,detection wavelength of 228 nm,and injection volume of 10 μL.RESULTS Impurity A,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Key words
Compound aminophenazone and barbital injection/Related substances/HPLC/Principal component self-control method with correction factor/Content determination引用本文复制引用
基金项目
重庆市技术创新与应用发展专项资助项目(CSTB2022TIAD-GPX0071)
出版年
2024
NETL
NSTL
万方数据