摘要
通过优化并统一法罗培南钠制剂(片剂、胶囊剂及颗粒剂)的HPLC含量测定方法,对国产法罗培南制剂含量进行研究探讨。实验采用Welch Ultimate XB-C_(18)色谱柱(4.6 mm×150 mm,5μm),柱温30℃;流动相为磷酸盐缓冲液(含磷酸二氢钾4.8 g、磷酸氢二钠5.4 g及溴化四丁基铵1.0 g,加水溶解并稀释至1 000 mL)-乙腈-甲醇(75:10:15),流速1.0 mL/min,检测波长305 nm,进样量20μL。结果显示,法罗培南峰与S-异构体峰分离良好;法罗培南在0.06~0.37 mg/mL浓度范围内与峰面积呈良好线性关系;方法精密度、准确度及耐用性均符合分析要求。优化后的方法灵敏度高、分离效果佳、分析时间短,适用于国产制剂的含量测定,可为国产制剂含量统一评价提供参考。
To optimize and unify HPLC method for the content determination of faropenem sodium preparations(tablets,capsules and granules),the content of domestic faropenem preparations was investigated.An Welch Ultimate XBC_(18) column(4.6 mm×150 mm,5μm)was employed,with a column temperature set at 30℃.The mobile phase comprised phosphate buffer(prepared by dissolving 4.8 g of potassium dihydrogen phosphate,5.4 g of disodium hydrogen phosphate,and 1.0 g of tetrabutylammonium bromide in water and diluting to 1000 mL),acetonitrile and methanol(75:10:15),flowing at 1.0 mL/min.Detection was conducted at 305 nm with an injection volume of 20μL.Results indicated good separation between the faropenem peak and its S-isomer peak faropenem displayed a favorable linear relationship with peak area in the concentration range of 0.06 mg/mL to 0.37 mg/mL,and the method′s precision,accuracy and robustness all met analytical requirements.The optimized method,characterized by high sensitivity,excellent separation efficiency,and short analysis time,was applicable for the content determination of domestic faropenem preparations and provided a reference for the unified evaluation of their contents.
作者
韩芸
HAN Yun(Institute for Drug Control of Hainan Academy of Inspection and Testing,Hainan Haikou 570216,China)
出处
《广州化工》
2026年第2期56-59,共4页
GuangZhou Chemical Industry
基金
2022年国家药品评价性抽检资助国药监药管(No.[2022]1号)。
关键词
法罗培南钠制剂
含量测定
高效液相色谱法
方法优化
标准完善
faropenem sodium preparations
content determination
HPLC
method optimization
standard improvement
