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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
【摘要】 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 C18(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。
【Abstract】 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 1ml·min-1,and column temperature was 25℃.Result;The linear rang was 2.5 -50μg·ml-1.Detection limit was 0.lng·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.
- 【文献出处】 中国药师 ,China Pharmacist , 编辑部邮箱 ,2009年07期
- 【分类号】R927.2
- 【被引频次】3
- 【下载频次】150