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

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.