HPLC法测定氢溴酸高乌甲素注射液有关物质的研究  

HPLC determination of related substance of lappaconite hydrobromide injection

作　　者：刘朝霞[1] 黄海伟[1] 张启明[1] 丁丽霞[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2009年第5期795-798,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定氢溴酸高乌甲素注射液有关物质的高效液相色谱法。方法:色谱柱为SHIMADZU VP-ODS(150mm×4.6mm,5μm),以0.025mol·L-1磷酸二氢钠-甲醇(60∶40,用磷酸调pH至4.0)为流动相,检测波长为252nm,流速为1.0mL·min-1,柱温为25℃。结果:在该色谱条件下,杂质峰与主峰均能良好分离;氢溴酸高乌甲素的检出限为6ng;氢溴酸高乌甲素浓度在2.002～200.2μg·mL-1范围内,线性良好,线性方程A=2.637C+1.416×104,r=0.9997。结论:本方法快速灵敏,准确实用,适用于氢溴酸高乌甲素注射液有关物质的测定。Objective： To establish an HPLC method for determination of related substance of lappaconite hydrobromide injection. Methods： The HPLC system consisted of SHIMADZU VP-ODS column（ 150 mm×4.6 ram,5 μm） ,methanol -0. 025 mol·L^-1 NaH2PO4 solution（adjust to pH 4.0 with phosphoric acid） （60： 40） as the mobile phase with DAD detection at 252 nm, flow rate ： 1.0 mL·min^-1, column temperature ： 25 ℃. Results ： Good resolution for lappaconite hydrobromide and related substances was obtained. The detection limits for lappaconite hydrobromide were 6. 0 ng. The linear range was 2. 002 - 200. 2 μg·mL^-1 （ r = 0. 9997 ）. Conclusion： The method is simple, sensitive,accurate and can be used for determination of related substance of lappaconite hydrobromide injection.

关 键 词：氢溴酸高乌甲素注射液 有关物质测定 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]