HPLC法测定止痛贴中补骨脂素和异补骨脂素的含量

Determination of psoralen and isopsoralen in Zhitong Plaster by HPLC

目的建立高效液相色谱法测定止痛贴中补骨脂素、异补骨脂素的含量。方法色谱柱:PhenomenexGemini C18(4.6 mm×250 mm,5μm);流动相:乙腈-0.1%甲酸(35∶65);检测波长:246 nm;柱温:室温;流速:1.0mL.min-1。结果补骨脂素线性范围为0.081 3～0.487 7μg(r=0.999 9),平均回收率为99.85%(n=6),RSD为0.96%。异补骨脂素线性范围为0.081 6～0.489 6μg(r=0.999 9),平均回收率为101.25%(n=6),RSD为1.20%。结论方法稳定、可靠,可作为该制剂的质量控制方法。

Objective To establish an HPLC method for the determination psoralen and isopsoralen in Zhitong Plaster.Methods Psoralen and isopsoralen were assayed on an Phenomenex Gemini C18（4.6 mm ×250 mm,5 μm） column;The mobile phase composed of acetonitrile-0.1% phosphoric acid solution（35∶65） at a flow rate of 1.0 mL.min-1;The detection wavelength was 246 nm.Results The calibration curves were linear in the range of 0.081 3 ～ 0.487 7 μg（r = 0.999 9） for psoralen and 0.081 6 ～ 0.489 6 μg（r =0.999 9） for isopsoralen,respectively.The average recoveries（n =6） of psoralen and isopsoralen were 99.21%（RSD = 1.48%） and 101.42%（RSD = 0.76%）,respectively.Conclusion The method was proved to be simple and reliable,accurate,repeatable and can be used for quality control of Zhitong Plaster.