离子对高效液相色谱法测定多库酯钠的含量  

Determination of docusate sodium by ion-pair high-performance liquid chromatography

作　　者：蔡立荣 舒海平 肖莎 谭跃 郑金凤 李昌亮 刘雁鸣 CAI Lirong;SHU Haiping;XIAO Sha;TAN Yue;ZHENG Jinfeng;LI Changliang;LIU Yanming(Hunan Institute for Drug Control,NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001;NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparation and Excipients,Nanjing 211198;Hunan Warrant Pharmaceutical Co.,Ltd,Changsha 410006,China)

机构地区：[1]湖南省药品检验检测研究院,国家药监局药用辅料工程技术研究重点实验室,长沙410001 [2]国家药监局药物制剂及辅料研究与评价重点实验室,南京211198 [3]湖南华纳大药厂股份有限公司,长沙410006

出　　处：《中国药科大学学报》2025年第2期183-187,共5页Journal of China Pharmaceutical University

基　　金：湖南省自然科学基金科药联合基金项目(2023JJ60106);国家药监局药物制剂及辅料研究与评价重点实验室开放课题(PPE2023008)。

摘　　要：为降低对高载碳量色谱柱的依赖,优化并建立了多库酯钠含量测定的新型离子对高效液相色谱法(IP-HPLC)。采用四丙基氯化铵为离子对试剂,乙腈-10 mmol/L四丙基氯化铵水溶液(66∶34)为流动相,用0.1%磷酸溶液调pH至6.5,流速为1.5 mL/min,检测波长为214 nm,柱温为35℃,进样量为25μL,外标法测定。结果表明该方法专属性良好,主峰拖尾因子为1.34;在0.02~0.40 mg/mL范围内线性关系良好,相关系数r=0.9999;重复性结果良好,加样回收率97.0%~98.2%(n=6);定量限为3.31μg/mL;检测限为2.76μg/mL。总体来看,新方法耐用性好、线性范围宽、灵敏度高,适合用于测定多库酯钠的含量。To reduce the dependency on high-carbon-load chromatographic columns,a new method has been established for the determination of the content of docusate sodium using ion-pair high-performance liquid chromatography(IP-HPLC).Tetrapropylammonium chloride was used as the ion-pair reagent with a mobile phase,composition of acetonitrile:10 mmol/L tetrapropylammonium chloride solution=66∶34,adjusting pH to 6.5 with 0.1% phosphoric acid solution,flow rate of 1.5 mL/min,detection wavelength of 214 nm,column temperature of 35℃,and an injection volume of 25μL,and quantified by an external standard method.The main peak of docusate sodium exhibited a tailing factor of 1.34.The method showed good linearity within the range of 0.02 mg/mL to 0.40 mg/mL,with a correlation coefficient(r)of 0.9999.It also demonstrated good repeatability,with recovery ranging from 97.0% to 98.2%(n=6).The quantification limit was 3.31μg/mL,and the detection limit was 2.76μg/mL.In summary,the new method shows good durability,a wide linear range,and high sensitivity,it is suitable for the determination of docusate sodium.

关 键 词：多库酯钠 离子对 高效液相色谱法 高载碳量色谱柱 

分 类 号：R917[医药卫生—药物分析学]