摘要
目的采用替代对照品法测定奥硝唑注射液中的3种已知杂质。方法采用Agela Venusil MP C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-水-冰乙酸(20∶80∶0.1),流速1.2 mL·min^(-1),柱温35℃,检测波长318 nm。采用相对校正因子计算3种已知杂质的含量。结果在选定的色谱条件下,主药和3种已知杂质的出峰顺序依次为杂质Ⅰ、杂质Ⅱ、杂质Ⅲ、奥硝唑,各峰间的分离度均符合规定,各杂质的检出限依次为0.05、0.06、0.10 ng。替代对照品法所得结果与外标法基本一致。结论所用方法操作简单、成本低、实用性强、专属性强,可用于奥硝唑注射液的杂质检查。
OBJECTIVE To determine three related substances in Ornidazole injection by Substitute reference substance.METHODS The separation was performed on Agela Venusil MP C_(18) column with iaocratic elution.The flow rate was 1.2 mL·min^(-1),and the detection wavelength was 318 nm.Relative correction factors were used to calculate the content of three known impurities.RESULTS Ornidazole and its related substances could be completely separated by the method,and the detection limit was 0.05 ng,0.06 ng and 0.10 ng,separately.There was no significant difference between the results measured by the established method and by the external standard method.CONCLUSION The method is simple,economical,feasible and reliable.It is provided for determination related substances.
作者
王柳
田晓彤
路惬楠
张轶华
WANG Liu;TIAN Xiaotong;LU Qienan;ZHANG Yihua(Hebei Institute for Drug and Medical Device Control,Shijiazhuang,Hebei,050022 P.R.China)
出处
《华西药学杂志》
CAS
CSCD
2022年第4期435-439,共5页
West China Journal of Pharmaceutical Sciences
关键词
替代对照品法
相对校正因子
奥硝唑注射液
已知杂质
高效液相色谱法
分离度
检出限
外标法
Substitute reference substance
Relative correction factor
Ornidazole injection
Related substances
HPLC
Separation
Detection limit
External standard method
