HPLC法测定芬太尼透皮贴剂中芬太尼含量

Determination of Fentanyl in Fentanyl Transdermal Patch by HPLC

目的:采用高效液相色谱法测定芬太尼透皮贴剂中芬太尼含量。方法:采用内标法,用甲醇混合液90min超声提取样品。色谱柱为Shim-pack CLC-ODS C_(18)(250 mm×4.6 mm,5μm),以甲醇溶液(取甲醇400ml,乙腈200 ml,及冰醋酸0.6 ml,混匀)-0.2%无水硫酸钠的醋酸胺(1-100)(7∶3)并用冰醋酸调节pH(6.5±0.1)为流动相,流速1ml·min^(-1),柱温25℃,检测波长为230 nm。结果:芬太尼浓度在2.5～50μg·ml^(-1)范围内线性关系良好(r=0.999 9),最低检测限0.1 ng·ml^(-1),样品24h稳定,平均回收率为100.9%,RSD为1.27%。结论:本方法简便快速,结果准确,重现性好,适用于芬太尼透皮贴中芬太尼含量的测定。

Objective： To determine the content of fentanyl in fentanyl transdermal patch by HPLC. Method： Internal standard method was used. The Shim-pack CLC-ODS C18 column （250mm × 4.6mm,5μm） was used. The mobile phase consisted of liquid of methanol [ methanol ： acetonitrile ： acetic acid （400： 200：0.6 ） ] - 0.2% natrium sulfate, ammonium acetate （ 1 - 100 ） （ 7： 3 ） stirwell, by acetic acid make pH6.5 ± 0. 1, and detection wavelength was at 230nm. The flow rate was 1 ml· min^ - 1, and column temperature was 25℃. Result： The linear rang was 2.5 - 50μg· ml^ - 1. Detection limit was 0. 1ng· ml^ - 1 , The average recovery was 100.9%. The RSD was 1.27%. Conclusion： The method is simple ,accurate and sensitive ,and suitable to be used to determination the content of fentanyl in fentanyl transdermal patch.