HPSEC法检测美罗培南中聚合物杂质的测定研究  

Determination of the polymer impurities in Meropenem by HPSEC

作　　者：孙青 陈丹丹 戴红娟 Sun Qing;Chen Dandan;Dai Hongjuan(Management Committee of Taizhou Pharmaceutical High-tech Industrial Park,Taizhou 225300,China;Jiangsu Agri-animal Husbandry Vocational College,Taizhou 225300,China;Aurovitas Pharmaceutical Taizhou Co.,Ltd.,Taizhou 225300,China)

机构地区：[1]江苏省泰州医药高新技术产业园区管理委员会,江苏泰州225300 [2]江苏农牧科技职业学院,江苏泰州225300 [3]安若维他药业泰州有限公司,江苏泰州225300

出　　处：《江苏科技信息》2022年第9期54-58,共5页Jiangsu Science and Technology Information

摘　　要：文章建立了高效分子排阻色谱(HPSEC)法测定美罗培南中聚合物杂质的含量。采用TSK gel G2000SWXL凝胶色谱柱;检测波长为220 nm;柱温25℃;流动相为0.1%三乙胺溶液(用磷酸调至中性)-乙腈(95∶5);流速0.8 m L/min;进样体积20μL。结果表明:美罗培南峰与聚合物杂质峰分离良好;主峰的线性范围为0.0005~2 mg/m L(R=0.9999),聚合物杂质峰的线性范围为0.05~2 mg/m L(R=0.998);定量限为1.47μg/m L,检测限为0.49μg/m L,进样精密度RSD为0.4%(n=10)。聚合物杂质峰面积随美罗培南溶液放置时间延长而显著增长,表明美罗培南溶液不稳定,易产生聚合物杂质,溶液必须现配现用。所建方法专属性强、耐用性好、灵敏度高,适用于美罗培南中聚合物杂质的测定。This study establish a high performance size exclusion chromatography(HPSEC)method for determination of the polymer impurities in Meropenem.The analysis was carried out under the following conditions:chromatographic column was TSK gel G2000SWXL,the detection wavelength was 220 nm with the column temperature at 25℃,the mobile phase was 0.1%triethylamine solution(adjusted p H to 7.0 with phosphoric acid)-acetonitrile(95∶5)at a flow rate of 0.8 m L/min,the injection volume was 20μL.The polymer impurities were completely separated from Meropenem.For HPSEC method,the linear range of Meropenem peak was 0.0005-2 mg/m L(R=0.9999)and the linear range of the total impurities was 0.05-2 mg/m L(R=0.998).The limit of quantification(LOQ)was 1.47μg/m L and the limit of detection(LOD)was 0.49μg/m L.The relative standard deviation(RSD)for replicate injection was 0.4%(n=10).The peak area of polymer impurities increases significantly with the extension of standing time of the Meropenem test solution,which indicates that the Meropenem test solution is unstable and easy to produce polymer impurities.The Meropenem test solution must be prepared just before use.Conclusion:HPSEC method can be used to control the content of polymer impurities in Meropenem.The established method has strong specificity,good durability and high sensitivity.

关 键 词：高效分子排阻色谱法 美罗培南 聚合物杂质 

分 类 号：R917[医药卫生—药物分析学]