摘要
目的:建立苦参素注射液中苦参碱和氧化苦参碱的含量测定方法。方法:色谱柱为Acquity UPL- CBEH C18色谱柱(2.1 mm×100 mm,1.7μm);以10 mmol·L^(-1)醋酸胺水溶液(用氨水调节pH 8)-甲醇为流动相梯度洗脱;流速0.30 mL·min^(-1);柱温30℃;检测波长210 nm;进样量2μL。结果:苦参碱和氧化苦参碱分别在0.084～3.36μg和0.086～3.44μg呈现良好的线性关系,平均加样回收率分别为103.2%,98.7%;RSD分别为1.5%,1.2%。结论:本法简便、快速、准确,适用于该药品生产及临床应用中的质量监控。
Objective： To develop a method for the determination of matrine and oxymatrine in Kushensu injection by ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry （UPLC/Q-TOF-MS）. Method： The analysis was performed on a Acquity UPLC BEH C18 column （2.1 mm × 100 mm,1.7 μm） with the gradient elution of 10 mmol · L^-1 amine acetate （ pH 8, adjusted by aqueous ammonia） and methanol. The flow rate was set as 0. 30 mL · min^-1. The column temperature was maintained at 30 ℃. The peaks were detected at 210 nm and the injection volume was 2 μL. Result： The calibration curves showed good linearity within the test ranges of 0. 084-3.36 μg for matrine and 0. 086-3.44 μg for oxymatrine, respectively. The mean recoveries were 103.2%, 98.7 % , and the RSD were 1.5%, 1.2%, respectively. Conclusion： The established method is simple, rapid and sensitive, can be used for the quality control of matrine and oxymatrine in Kushensu injection through the manufacturing process and clinical implement.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2008年第12期1398-1401,共4页
China Journal of Chinese Materia Medica
基金
国家科技部国际合作项目(2006DFA02700)
关键词
超高效液相色谱
飞行时间质谱
苦参素注射液
苦参碱
氧化苦参碱
ultra high performance liquid chromatography （UPLC）
time-of-flight mass spectrometry （TOF-MS）
KushensuInjection
matrine
oxymatrine
