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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 high performance liquid chromatography. Methods: Internal standard method was used to extract the sample with methanol mixture for 90min. The column was Shim-pack CLC-ODS C_ (18) (250 mm × 4.6 mm, 5 μm) in methanol (400 ml of methanol, 200 ml of acetonitrile and 0.6 ml of glacial acetic acid) Sodium acetate (1-100) (7: 3) and the pH was adjusted to 6.5 ± 0.1 with glacial acetic acid. The flow rate was 1 ml · min -1 and the column temperature was 25 ℃. The detection wavelength was 230 nm. Results: The linear range was 2.5-50 μg · ml -1 (r = 0.999 9), the lowest detection limit was 0.1 ng · ml -1. The average recovery of fentanyl was 100.9%, RSD 1.27%. Conclusion: The method is simple, rapid, accurate and reproducible. It is suitable for the determination of fentanyl in fentanyl transdermal patch.