压敏胶贴片中芍药苷及残留溶剂含量的测定

Determination of Marked Component and Residual Solvents in Rupixiao Pressure Sensitive Adhesives Patch

建立了贴片中标示成分芍药苷含量的高效液相色谱(HPLC)法和贴片中各种残留溶剂含量的气相色谱(GC)法。样品经甲醇提取,离心分离后,以乙腈-水(含4%HAc)的体积比为16∶84作流动相,选择ODS-2HypersilC18(150×4.6mm,5μm)色谱柱,测定芍药苷含量。贴片基质经乙醚处理,离心分离,以GC内标法测定残留溶剂含量。结果表明:HPLC法的精密度、重现性和回收率良好;GC法测得乙酸乙酯、异丙醇、乙醇三种残留溶剂,贴片中残留溶剂总量为2.1×10-4,符合药典限度规定。

An HPLC and GC method was established to detect the content of paeoniflorin and residual solvents. The sample was separated with ODS-2 Hypersil C18 （150×4.6 mm,5 μm）column using acetonitrile-water （0.4% HAc）=16：84（V/V） as mobile phase,after being extracted by methanol and separated by centrifuge. The content of residual solvents was detected using GC internal standard method,after the matrix was dissolved in aether and separated by centrifuge. The results showed that the RSD and recoveries were good; Ethyl acetate,isopropanol,ethanol were detected by GC,with a total content of residual solvents 2.1×10-4,which is consistent with the standard in Chinese Pharmacopeia （CHP）.