摘要
目的:建立一种测定酮咯酸氨丁三醇注射液有关物质的高效液相色谱法。方法:采用Alhima-C_(18)(250 mm×4.6 mm,5μm)色谱柱,以0.02 mol·L^(-1)磷酸二氢铵溶液(用磷酸调pH至3.0)-乙腈(65:35)为流动相;流速1.2 ml·min^(-1);柱温40℃;检测波长为313 nn;进样量为20μl。结果:酮咯酸氨丁三醇峰与各杂质峰均能良好的分离。3批样品有关物质分别为0.15%、0.13%、0.12%,均符合规定。结论:本方法简便、灵敏、专属性好,可用于酮咯酸氨丁三醇注射液有关物质的检查。
Objective： To establish an HPLC method for the determination of the related substances in ketorolac tromethamine injections. Method： An Alltima-C18 column（250 mm × 4.6 mm,5 μm）was used with 0.02 mol · L-1 monobasic ammonium phosphate （ adjusting pH to 3.0 with phosphoric acid） -acetonitrile （65： 35 ） as the mobile phase. The flow rate was 1.2 ml · min - 1, the detection wavelength was at 313 nm, the column temperature was 40℃ and the injection volume was 20 μl. Result： The separation of ketorolac tromethamine and its impurities was good. The content of the related substances in 3 batchs of ketorolac tromethamine injections was 0.15%, 0.13% and 0.12%, respectively. Conclusion： The method is simple, sensitive and specific. It is suitable for the determination of the related substances in ketorolac tromethamine injections.
出处
《中国药师》
CAS
2012年第7期940-941,共2页
China Pharmacist
基金
2008年国家火炬计划项目(编号:2008GH021181)
