摘要
目的:建立乳酸依沙吖啶注射液含量及其有关物质的测定方法。方法:用高效液相色谱(HPLC)法,Waters Xterra MS C18柱(250×4.6mm,5μm);含0.1%辛烷磺酸钠的[乙腈-磷酸盐缓冲液(7.8g磷酸二氢钠加900ml水溶解,并用磷酸调pH至2.8,加水稀释至1000ml,即得)(300:700)]为流动相;检测波长为270nm。结果:乳酸依沙吖啶进样量0.05295～2.1180μg与峰面积的线性关系良好(r=0.9998);平均回收率为99.84%,100.05%,100.16%;RSD为0.32%,0.15%,0.41%(n=3),最低检测限为10.75ng。结论:所建方法准确、简便、快速,适用于乳酸依沙吖啶注射液的质量控制。
Objective：To determine the content and related substances of ethacridine lactate injection by RP-HPLC. Methods：Us- ing Waters Xterra MS C18 column （4.6 mm×250 mm,5μm）, the mixture of acetonitrile-phosphate buffer solution containing 0.1% octanesulfonate freshly prepared （dissolving 7.8 g of sodium dihydrogen phosphate in 900 ml of water, adjusting to pH2.8 with sodium hydroxide and phosphoric acid,adding water to 1000 ml,mixing well） as the mobile phase,the detection wave-length was 270 nm. Results：The calibration curves showed good linearity over the range of 0.05295-2.1180 μg,r=-0.9998 ;the average recoveries were 99.84%, 100.05% and 100.16%,RSD were 0.32%,0.15% and 0.41%（n=3）. the LOD was 10.75ng. Conclusion：The method is simple,rapid,accurate and suitable for testing related substances of ethacridine lactate injection and content determination.
出处
《现代医药卫生》
2009年第7期996-997,共2页
Journal of Modern Medicine & Health
