高效分子排阻色谱法测定氨苄西林钠聚合物

Determination of the Polymers in Ampicillin Sodium by HPSEC

建立高效分子排阻色谱法(HPSEC)测定氨苄西林钠中聚合物含量。采用TSK-gel G2000SWXL柱(7.8mm×30cm,5μm);流动相为磷酸盐缓冲液(pH7.0)[0.01mol·L-1磷酸氢二钠溶液-0.01mol·L-1磷酸二氢钠溶液(61:39)]:乙腈(95:5);流速为0.7m L/min;检测波长为230nm;柱温为30℃。氨苄西林的线性范围为0.4~4.8mg/mL(r=0.9995),浓度与峰面积呈良好线性关系;定量限为10.8 ng,检测限为4.2ng。该方法准确可靠、重复性好、专属性强,能有效测定氨苄西林钠中聚合物的含量。

Establishment of High Performance Molecular Exclusion Chromatography(HPSEC)for the Determination of Polymers Content in Ampicillin Sodium.The analysis was carried out using a TSK-gel G2000 SWXL column(7.8 mm×30 cm,5μm).The mobile phase was phosphate buffer(pH7.0)[0.01 mol·L-1 Na2HPO4 solution-0.01 mol·L-1 NaH2PO4 solution(61:39)]:acetonitrile(95:5)at the flow rate of 0.7 mL/min.The detection wavelength was 230 nm and the column temperature was 30℃.The linear range of Ampicillin was 0.4~4.8 mg/mL(r=0.9995),and the relationship between concentration and peak area was good.The limit of quantification of this method was 10.8 ng,and the detection limit was 4.2 ng.The method was accurate,reliable,reproducible and specific,and can effectively determined the content of Polymers in Ampicillin Sodium.