注射用法罗培南钠差向异构体的HPLC法测定

Determination of Epimer of Faropenem Sodium for Injection by HPLC

建立了高效液相色谱法测定注射用法罗培南钠差向异构体。使用C18色谱柱,以磷酸盐缓冲液（称取磷酸二氢钾6.12 g、十二水合磷酸氢二钠1.79 g与溴化四丁铵1.61 g,溶于1 L水中）为流动相A,以流动相A∶乙腈（1∶1）为流动相B,梯度洗脱,检测波长240 nm。法罗培南钠差向异构体在0.15～1.80μg/ml范围内线性关系良好,最低检测限为0.06μg/ml,最低定量限为0.30μg/ml。平均回收率为99.9%,RSD为1.13%。

An HPLC method was established for the determination of the epimer of faropenem sodium for injection. A C18 column was used, with the mobile phase A of phosphate buffer （added 6.12 g of potassium dihydrogen phosphate, 1.79 g of disodium hydrogen phosphate dodecahydrate and 1.61 g of tetrabutyl ammonium bromide to 1 L of water） and the mobile phase B ofA ： acetonitrile （1 ： 1） by gradient elution, at the detection wavelength of 240 nm. It was linear for the epimer in the range of 0.15 - 1.80 μg/ml, with LLOD of 0.06 μg/ml and LLOQ of 0.30 μg/ml. The average recovery was 99.9 %, with RSD of 1.13 %.