HPLC法测定氢溴酸高乌甲素注射液有关物质的研究___

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（150 mm×4.6 mm，5 μm），以0.025 mol·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252 nm，流速为1.0 mL·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6 ng；氢溴酸高乌甲素浓度在2.002~200.2 μg·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。

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

 Abstract   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 mm，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.

Key words:lappaconite hydrobromide injection；related substance determination；HPLC