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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 a HPLC method for the determination of related substances in Lappaconitine hydrobromide injection. METHODS: The chromatographic column was SHIMADZU VP-ODS (150mm × 4.6mm, 5μm). The mobile phase consisted of 0.025mol·L-1 sodium phosphate monobasic acid (60:40, adjusted to pH 4.0 with phosphoric acid) 252nm, the flow rate was 1.0mL · min-1, the column temperature was 25 ℃. Results: Under the chromatographic conditions, the impurity peak and the main peak were well separated. The detection limit of lappaconitine hydrobromide was 6ng and the concentration of lappaconitine hydrobromide was in the range of 2.002 ~ 200.2μg · mL-1 , Good linearity, the linear equation A = 2.637C + 1.416 × 104, r = 0.9997. Conclusion: The method is fast, sensitive, accurate and practical and is suitable for the determination of related substances in Lappaconitine hydrobromide injection.