HPLC法控制丹参素异丙酯质量

Quality control of isopropyl β-(3,4-dihydroxyphenyl)-α-hydroxypropanoate by HPLC

目的:建立以高效液相色谱法控制丹参素异丙酯质量的方法。方法:色谱柱为Agilent HC-C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.2%甲酸水(30∶70),流速:0.8 mL/min,检测波长:284 nm,柱温:25℃,进样量:10μL。结果:丹参素异丙酯主峰与其他杂质峰分离良好,线性范围为5～500μg/mL(r=0.999 9);低、中、高3个浓度加样回收率(%)分别为100.03,100.87和100.27,RSD(%)分别为0.53,0.23和0.50。结论:该方法准确、灵敏、专属性好,可用于丹参素异丙酯的质量控制。

Aim： To establish an HPLC method for the determination of isopropyl β-（3, 4-dihydroxyphenyl） - α- hydroxypropanoate. Methods： Separation was achieved on an Agilent HC-C18column （150 mm × 4. 6 mm, 5 μm） with the mobile phase consisting of methanol-0. 2% formic acid （ 30 ： 70）, at a flow-rate of 0. 8 mL/min. The detection wavelength was set at 284 nm. The column oven temperature was 25 ℃. The injection volume was 10 μL Results： A good resolution with baseline separation was obtained. The calibration was linear in the range of 5-500 μg/mL （r =0. 999 9）. The recoveries of three concentrations （ 10, 100,400 μg/mL） were 100. 03%, 100. 87% and 100. 27%, respectively; and the RSDs were 0. 53%, 0. 23% and 0. 50%, respectively. Conclusion： The developed method is accurate, sensitive and suitable for quality control of isopropyl β-（ 3, 4-dihydroxy- phenyl）-α-hydroxypropanoate.