RP-HPLC法测定呱氨托美丁及有关物质

RP-HPLC determination of Amtolmetin guacil and its related substances

建立了呱氨托美丁及有关物质的RP-HPLC检测方法.采用Agilent C18(250 mm×4.6 mm, 5 μm)色谱柱,以甲醇-乙腈-0.015 mol/L的KH2PO4溶液(V(甲醇):V(乙腈):V(KH2PO4)＝30:30:40)(用体积分数8.5%的H3PO4水溶液调至pH 5.3)为流动相,检测波长313 nm,流速1.0 mL/min.呱氨托美丁在10～3000 μg/mL 范围内,峰面积与质量浓度呈良好线性关系(r=0.9999),平均回收率99.86%,RSD=0.82%.采用反相高效液相色谱法测定呱氨托美丁及有关物质,能有效控制呱氨托美丁的质量.

A RP-HPLC method was established for the determination of Amtolmetin guacil and its related substances. The separation was performed on a Agilent C18 column（250 mm× 4.6 mm, 5 μm）. The mobile phase was methanol-acetontrile-monopotassium phosphate buffer （0.015 mol/L） =30：30：40（v/v/v） （adjust pH to 5.3 with H3 PO4 ） . The detection was carried out with a uv detector at 313 nm. The flow rate was 1 .0 mL/min. The linear range of Amtolmetin guacil was 10 - 3000 μg/mL （r = 0.9999）. The recovery was 99.86%, and RSD is 0.82%. This method is suitable for the determination of Amtolmetin guacil and its related substances. The method is used to effectively control the quality of Amtolmetin guacil.