凝胶色谱法测定法罗培南钠颗粒高分子杂质的含量

目的建立使用凝胶色谱法测定法罗培南钠颗粒中法罗培南聚合物的方法.方法采用葡萄糖凝胶G-10(40～120μm)为色谱柱(不锈钢内径为1.3 cm,柱高度为40 cm);以pH7.0的0.1 mol爛L-1磷酸盐缓冲液0.1 mol爛L-1磷酸氢二钠溶液-0.1 mol爛L-1磷酸二氢钠溶液(61∶39)]流动相A,以水为流动相B,流速:1.0 mL爛min-1,检测波长:254 nm.结果法罗培南钠以法罗培南计浓度在5.1～81.6μg爛mL-1范围内,呈良好的线性关系,相关系数为1.0;供试品溶液以法罗培南计浓度在55.14～551.40 mg爛mL-1范围内,与法罗培南聚合物峰面积呈良好的线性关系,相关系数为0.995 6.结论该方法简便、数据可靠、重现性好.

Determination of the polymers in Faropenem Sodium Granules by gel chromatography

Objective To establish a gel chromatography method for the determination of polymers in Faropenem Sodium Grannules. Methods The column was Sephadex G - 10 （ 1.3 cm × 40 cm） ,with 0.1 mol · L- 1 phosphate buffer solution pH7. 0,0.1 mol · L-1 disodium phosphate - 0.1 mol · L- 1 sodium dihydrogen phosphate （ 61 ： 39 ） ] , as mobile, phase A and water as mobile phase B. The flow rate was 1.0 mL ·min- 1. The detection wavelength was 254 nm. Results The linear ranges of faropenenm was 5.1 -81.6μg · mL-1 （r = 1. 000 0） , and the test sample solution was linear in the concentration range of 55.14 -551.40 mg · mL-1 （ r = 0. 995 6 ） with polymer in faropenenm. Conclusion This gel chromatography method was simple, reliable and reproducible.