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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第5期795-798,共4页
Chinese Journal of Pharmaceutical Analysis
