HPLC法测定奥拉西坦原料药中的有关物质
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摘要
目的:建立测定奥拉西坦原料药有关物质的方法。方法:采用高效液相色谱法。色谱柱为月旭XB-C18,流动相为0.01mol/L磷酸二氢钾溶液(pH 3.0),流速为0.8 ml/min,检测波长为214 nm。结果:在选定的色谱条件下,主峰和相邻杂质峰能较好地分离;奥拉西坦检测质量浓度线性范围为0.210 4~0.631 2μg/m(lr=0.999 7,n=5),检测限为0.95 ng。结论:本方法准确、简便,专属性强,灵敏度高,可用于奥拉西坦原料药的质量控制。
OBJECTIVE:To establish a method for the determination of oxiracetam raw material. METHODS:HPLC method was adopted. The determination was performed on Welch XB-C18 column with 0.01 mol/L potassium dihydrogen phosphate(pH adjusted to 3.0)as mobile phase at the flow rate of 0.8 ml/min. The detection wavelength was set at 214 nm. RESULTS:At the selected chromatographic conditions,the prominent peak and the neighbor subsidiary peak could be well separated;the linear range of oxiracetam was 0.210 4-0.631 2 μg/ml(r=0.999 7,n=5),with the detection limit of 0.95 ng. CONCLUSIONS:The method is accurate,convenient,specific,sensitive and suitable for the quality control of oxiracetam raw material.
OBJECTIVE:To establish a method for the determination of oxiracetam raw material. METHODS:HPLC method was adopted. The determination was performed on Welch XB-C18 column with 0.01 mol/L potassium dihydrogen phosphate(pH adjusted to 3.0)as mobile phase at the flow rate of 0.8 ml/min. The detection wavelength was set at 214 nm. RESULTS:At the selected chromatographic conditions,the prominent peak and the neighbor subsidiary peak could be well separated;the linear range of oxiracetam was 0.210 4-0.631 2 μg/ml(r=0.999 7,n=5),with the detection limit of 0.95 ng. CONCLUSIONS:The method is accurate,convenient,specific,sensitive and suitable for the quality control of oxiracetam raw material.
引文
[1]刘治军,胡欣.促智药奥拉西坦的临床和基础研究[J].中华神经外科疾病研究杂志,2005,4(3):286.
[2]Nicolaus BJR.Chemistry and pharmacology of nootropics[J].Drug Dev Res,1982,2(6):463.
[3]Soldtos CTM.CNS effects of ISF2522,a new nootropic[J].Curr Ther Res,1979,26(7):525.
[4]孙琛.临床用药大全[M].北京:中国大百科全书出版社,1995:106.
[5]於冬晖,焦效兰,周玉娟,等.国产奥拉西坦胶囊的人体耐受性及药代动力学研究[J].中国临床药理学杂志,1997,13(1):11.
[6]国家食品药品监督管理局.WS-1005(X-750)-2002奥拉西坦:试行[S].2003-01-28.
[7]国家食品药品监督管理局.YBH06612003奥拉西坦:试行[S].2003-09-27.
[8]Lecaillon JB,Souppart C,Leduigou F,et al.Determination of oxiracetam in plasma and urine by column switching high-performance liquid chromatography[J].Chromatogr,1989,497(6):223.
[9]国家药典委员会.中华人民共和国药典:二部[S].2010年版.北京:中国医药科技出版社,2010:附录29.
[10]钟明康,张静华,陆丛笑.高效液相色谱法测定血浆中格列吡嗪的浓度[J].中国临床药学杂志,1999,8(3):172.
[11]闫小燕,胡欣,曹国颖.高效液相色谱法测定奥拉西坦氯化钠注射液中主药的含量[J].中国药房,2006,17(8):618.
[12]湛建峰,黄海伟,刘朝霞,等.HPLC法测定奥拉西坦氯化钠注射液中奥拉西坦含量及其有关物质[J].药物分析杂志,2009,29(12):2077.
[2]Nicolaus BJR.Chemistry and pharmacology of nootropics[J].Drug Dev Res,1982,2(6):463.
[3]Soldtos CTM.CNS effects of ISF2522,a new nootropic[J].Curr Ther Res,1979,26(7):525.
[4]孙琛.临床用药大全[M].北京:中国大百科全书出版社,1995:106.
[5]於冬晖,焦效兰,周玉娟,等.国产奥拉西坦胶囊的人体耐受性及药代动力学研究[J].中国临床药理学杂志,1997,13(1):11.
[6]国家食品药品监督管理局.WS-1005(X-750)-2002奥拉西坦:试行[S].2003-01-28.
[7]国家食品药品监督管理局.YBH06612003奥拉西坦:试行[S].2003-09-27.
[8]Lecaillon JB,Souppart C,Leduigou F,et al.Determination of oxiracetam in plasma and urine by column switching high-performance liquid chromatography[J].Chromatogr,1989,497(6):223.
[9]国家药典委员会.中华人民共和国药典:二部[S].2010年版.北京:中国医药科技出版社,2010:附录29.
[10]钟明康,张静华,陆丛笑.高效液相色谱法测定血浆中格列吡嗪的浓度[J].中国临床药学杂志,1999,8(3):172.
[11]闫小燕,胡欣,曹国颖.高效液相色谱法测定奥拉西坦氯化钠注射液中主药的含量[J].中国药房,2006,17(8):618.
[12]湛建峰,黄海伟,刘朝霞,等.HPLC法测定奥拉西坦氯化钠注射液中奥拉西坦含量及其有关物质[J].药物分析杂志,2009,29(12):2077.