摘要
目的建立检测依达拉奉注射液中有关物质含量的高效液相色谱法。方法色谱柱为Tianhe Kromail C18柱(250 mm×4. 6 mm,5μm);以0. 02 mol/L磷酸二氢铵溶液-甲醇(55∶45,V/V,用20%磷酸溶液调p H至3. 0)为流动相A,以0. 02 mol/L磷酸二氢铵溶液-甲醇(25∶75,V/V,用20%磷酸溶液调pH至3. 0)为流动相B,梯度洗脱,流速为1. 0 m L/min,柱温为35℃,检测波长为245 nm。以主成分自身对照法计算有关物质含量。结果主成分与有关物质能完全分离,各杂质峰分离良好;各已知杂质不同质量浓度的平均回收率均在99. 46%～101. 57%之间,RSD均小于4. 1%(n=9);各批次依达拉奉注射液中总杂质含量均不大于0. 3%。结论该方法专属性强、灵敏度高、重复性好,可用于依达拉奉注射液中有关物质的检测。
Objective To establish an HPLC method for the content determination of related substances in Edaravone Iniection. Methods The chromatographic column was Tianhe Kromail C18 column( 250 mm × 4. 6 mm,5 μm),the mobile phase A consisted of 0. 02 mol/L ammonium dihydrogen phosphate-methanol( 55 ∶ 45,V/V,20% phosphoric acid was used to adjust pH to 3. 0),the mobile phase B consisted of 0. 02 mol/L ammonium dihydrogen phosphate-methanol( 25 ∶ 75,V/V,20% phosphoric acid was used to adjust p H to3. 0),gradient elution,the flow rate was 1. 0 m L/min,the column temperature was 35 ℃,the detection wavelength was 245 nm. The content of related substance was calculated by self-control with main components. Results The main components and related substances were completely separated,and the impurity peaks were separated well from each other. The average recoveries of all known impurities in different concentrations ranged from 99. 46% to 101. 57%,and RSDs were less than 4. 1%( n = 9). The content of total impurities in Edaravone Injection in each batch was not more than 0. 3%. Conclusion The method is specific,sensitive and reproducible,which can be used for the content determination of related substances in Edaravone Injection.
作者
杨清举
张弘
YANG Qingju;ZHANG Hong(Jintang First People’s Hospital,Jintang Hospital Affiliated to West China Hospital of Sichuan University,Chengdu,Sichuan,China610400;Rakon Technologies Co.,Ltd.,Chengdu,Sichuan ,China 611731)
出处
《中国药业》
CAS
2019年第10期31-34,共4页
China Pharmaceuticals
