HPLC法测定甲磺酸酚妥拉明注射液中5-羟甲基糠醛的含量

HPLC determination of 5-Hydroxymethyl-furfural in Phentolamine Mesylate Injection

目的:建立高效液相色谱法测定甲磺酸酚妥拉明注射液中5-羟甲基糠醛的含量。方法:色谱柱为 Prodigy 5 μm ODS3100A 柱(150 mm×4.60 mm,5 micron);流动相为甲醇-水-冰醋酸(95:205:2);流速为0.8 mL·min^(-1),柱温15℃,检测波长284 mm,进样量20 μL,检出限为1.2 μg·L^(-1)。结果:5-羟甲基糠醛进样量与峰面积呈良好的线性关系,线性范围为4.0～20.0ng,r=0.99995(n=5)。结论:所建立办法简便、灵敏、准确可靠,专属性强。

Objective： To establish an HPLC method to determine the content of 5 -Hydroxymethyl -furfural in Phentolamine Mesylate Injection. Method： A Prodigy 5 μm ODS3 100A column （ 150 mm × 4.60 mm, 5 micron） was used, and the mobile phase was methanol - water - Acetic acid （95 ： 205 ： 2 ） , the flow rate was 0. 8 mL · min - ^1, the temperature of column was 15 ℃ ,the detection wavelength was at 284 nm with injection volume of 20 μL,the detection limit was 1.2 μg · L^-1. Results： the linear range was 4.0 - 20.0 ng, r = 0. 99995 （ n = 5 ）. Conclusion： The method is simple, sensitive, specific and accurate.