HPLC法测定依达拉奉注射液中的有关物质
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摘要
目的建立高效液相色谱法测定依达拉奉注射液的有关物质。方法采用Agilent SB-C_(18)(4.6 mm×250 mm,5μm)色谱柱,流动相A为0.05 mol·L~(-1)磷酸二氢钾溶液(用三乙胺调节pH值至7.0),流动相B为甲醇,梯度洗脱,流速为1.0 mL·min~(-1),检测波长为243 nm,柱温30℃。结果依达拉奉及各杂质均能有效分离,在相应的浓度范围峰面积与浓度呈良好的线性关系,相关系数均大于0.999,平均回收率在95%～105%范围内。结论该方法专属性强,简便可靠、灵敏、准确,适用于依达拉奉注射液中的有关物质的测定。
Objective To establish an HPLC method for the determination of related substance in Edaravone Injection.Methods The analysis was performed on an Agilent SB-C_(18) column(4.6 mm×250 mm,5 μm) with gradient elution and the mobile phase A was 0.05 mol·L~(-1) potassium dihydrogen phosphate(adjust pH to 7.0 by triethylamine),the mobile phase B was methanol and the flow rate was 1.0 mL·min~(-1).The detection wavelength was 243 nm,and the column temperature was 30 ℃.Results Under the described chromatographic condition,the known impurities and the unknown impurities were successfully separated from each other.The correlation coefficient of impurities were all greater than 0.999 and the recoveries were between 95% and 105%.Conclusion The method was specific,simple and accurate and suitable for the determination of the related substances in Edaravone Injection.
Objective To establish an HPLC method for the determination of related substance in Edaravone Injection.Methods The analysis was performed on an Agilent SB-C_(18) column(4.6 mm×250 mm,5 μm) with gradient elution and the mobile phase A was 0.05 mol·L~(-1) potassium dihydrogen phosphate(adjust pH to 7.0 by triethylamine),the mobile phase B was methanol and the flow rate was 1.0 mL·min~(-1).The detection wavelength was 243 nm,and the column temperature was 30 ℃.Results Under the described chromatographic condition,the known impurities and the unknown impurities were successfully separated from each other.The correlation coefficient of impurities were all greater than 0.999 and the recoveries were between 95% and 105%.Conclusion The method was specific,simple and accurate and suitable for the determination of the related substances in Edaravone Injection.
引文
[1] 许真玉.依达拉奉注射液杂质谱分析[J].中国执业药师,2014,11(8):27-30.
[2] 国家药典委员会.中华人民共和国药典2015年版(二部)[S].北京:中国医药科技出版社,2015:670-671.
[3] PMDA.ラジカット点滴静注バッグ30mg [EB/OL].http://www.info.pmda.go.jp/go/interview/1/400315_1190401G1026_1_200_1F.
[4] 董继胜,黄利朋,马歆茹.依达拉奉注射液质量研究[J].黑龙江医药,2010,23(3):340-342.
[5] 陈楠,盖春燕,陈刚,等.依达拉奉注射剂质量标准和稳定性研究[J].河北医药,2014,36(14):2098-2100.
[6] 刘伟芬,李禄辉,陈运来,等.依达拉奉氯化钠注射液处方及工艺研究[J].河南大学学报(医学版),2015,34(3):175-176,189.
[7] 方国民,任军.依达拉奉注射液的制备工艺研究[J].中国药业,2003,12(7):45-46.
[8] 林冠雄,廖荣寿.依达拉奉注射液制剂处方及工艺的研究[J].海峡药学,2005,17(5):21-24.
[2] 国家药典委员会.中华人民共和国药典2015年版(二部)[S].北京:中国医药科技出版社,2015:670-671.
[3] PMDA.ラジカット点滴静注バッグ30mg [EB/OL].http://www.info.pmda.go.jp/go/interview/1/400315_1190401G1026_1_200_1F.
[4] 董继胜,黄利朋,马歆茹.依达拉奉注射液质量研究[J].黑龙江医药,2010,23(3):340-342.
[5] 陈楠,盖春燕,陈刚,等.依达拉奉注射剂质量标准和稳定性研究[J].河北医药,2014,36(14):2098-2100.
[6] 刘伟芬,李禄辉,陈运来,等.依达拉奉氯化钠注射液处方及工艺研究[J].河南大学学报(医学版),2015,34(3):175-176,189.
[7] 方国民,任军.依达拉奉注射液的制备工艺研究[J].中国药业,2003,12(7):45-46.
[8] 林冠雄,廖荣寿.依达拉奉注射液制剂处方及工艺的研究[J].海峡药学,2005,17(5):21-24.