高效液相色谱法检测注射用帕瑞昔布钠中有关物质  

Gradient elution HPLC for related substances in parecoxib sodium for injection

作　　者：李昌亮 马晓宁 

机构地区：[1]湖南省食品药品检验研究院,长沙410001

出　　处：《中南药学》2014年第3期268-270,共3页Central South Pharmacy

摘　　要：目的建立检测注射用帕瑞昔布钠有关物质的HPLC检测方法。方法色谱柱为Agilent C18(150mm×4.6 mm,5μm),梯度洗脱,流速1 mL·min-1,检测波长为215 nm。结果在调整后的流动体系下,帕瑞昔布峰与相邻杂质峰达到有效分离;样品溶液室温放置12 h,峰面积无明显变化,溶液稳定性较好;伐地昔布低、中、高浓度的回收率分别为100.2%、100.3%、99.4%。结论该方法准确、可靠、重现性好,可用于该药品的质量控制。Objective To develop an HPLC method to determine the relevant substances in parecoxib sodium for injection. Methods An Agilent C18 column（150 mm×4.6 mm, 5 μm） was used with gradient elution. The flow-rate was 1 mL·min-1. The detection wavelength was 214 nm. Results Parecoxib and the adjacent impurities were effectively separated. The sample solution was stable in 12 h at the room temperature. The average recoveries low, middle and high concentration of valdecoxib were 100.2%, 100.3% and 99.4%. Conclusion The method is accurate, reliable and reproducible, and can be used for the quality control of the preparation.

关 键 词：注射用帕瑞昔布钠 有关物质 梯度洗脱 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]